FDA 510(k) Applications for Medical Device:
Bone Grafting Material, Animal Source
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K140021 | CHIYEWON |
4568 W. 1ST ST. STE 104 | LOS ANGELES | CA | 90004 |
| K170541 | Collagen Matrix, Inc. |
15 Thornton Road | Oakland | NJ | 07436 |
| K171008 | Collagen Matrix, Inc. |
15 Thornton Road | Oakland | NJ | 07436 |
| K043034 | COLLAGEN MATRIX, INC. |
509 COMMERCE ST. | FRANKLIN LAKES, | NJ | 07417 |
| K140714 | COLLAGEN MATRIX, INC. |
15 THORNTON ROAD | OAKLAND | NJ | 07436 |
| K162158 | Collagen Matrix, Inc. |
15 Thornton Road | Oakland | NJ | 07436 |
| K202183 | Collagen Matrix, Inc. |
15 Thornton Road | Oakland | NJ | 07436 |
| K201859 | Collagen Matrix, Inc. |
15 Thornton Road | Oakland | NJ | 07436 |
| K240133 | Collagen Solutions, LLC |
6455 City West Pkwy | Eden Prairie | MN | 55344 |
| K163714 | Datum Dental Ltd |
1 Bat Sheva St., PO Box 6170 | Lod | 7116003 | |
| K193212 | DSM Biomedical |
735 Pennsylvania Drive | Exton | PA | 19431 |
| K092428 | ED. GEISTLICH SOEHNE AG FUER CHEMISCHE INDUSTRIE |
1300 I STREET, N.W. | WASHINGTON | DC | 20005 |
| K242510 | Geistlich Pharma AG |
Bahnhofstrasse 40 | Wolhusen | 6110 | |
| K120601 | GEISTLICH PHARMA AG |
555 TWELFTH STREET, NW | WASHINGTON | DC | 20004-1206 |
| K122894 | GEISTLICH PHARMA AG |
555 TWELFTH STREET, NW | WASHINGTON | DC | 20004-1206 |
| K240661 | Geistlich Pharma AG |
Bahnhofstrasse 40 | Wolhusen | 6110 | |
| K251786 | Geistlich Pharma AG |
Bahnhofstrasse 40 | Wolhusen | 6110 | |
| K112572 | GEISTLICH PHARMA AG |
555 TWELFTH STREET, NW | WASHINGTON | DC | 20004-1206 |
| K112575 | GEISTLICH PHARMA AG |
555 TWELFTH STREET, NW | WASHINGTON | DC | 20004-1206 |
| K251613 | Geistlich Pharma AG |
Bahnhofstrasse 40 | Wolhusen | 6110 | |
| K033815 | GEISTLICH-PHARMA |
1301 K STREET NW | WASHINGTON | DC | 20005 |
| K151542 | HIOSSEN INC. |
85 BEN FAIRLESS DR. | FAIRLESS HILLS | PA | 19030 |
| K090794 | IMPLADENT, LTD. |
198-45 FOOTHILL AVE. | HOLLISWOOD | NY | 11423 |
| K173594 | Institut Straumann AG |
Peter Merian Weg 12 | Basel | CH-4002 | |
| K170245 | Kensey Nash Corporation dba DSM Biomedical |
735 Pennsylvania Drive | Exton | PA | 19341 |
| K111816 | LUITPOLD PHARMACEUTICALS, INC. |
ONE LUITPOLD DR. | SHIRLEY | NY | 11967 |
| K231672 | MedPark Co., Ltd. |
24, Nakdong-daero 1570 beon-gil, | Buk-gu | ||
| K142040 | NIBEC CO LTD |
904 E. WINDSOR ROAD #102 | GLENDALE | CA | 91203 |
| K150079 | NIBEC CO, LTD |
IWOL ELECTRICITY-ELECTRONIC AGRO-INDUSTRIAL COMPLEX, 1127, | JINCHEON-GUN | 365-824 | |
| K113246 | NIBEC COMPANY, LIMITED |
4568 W. 1ST STREET | LOS ANGELES | CA | 90004 |
| K123876 | ODONTIT SA |
2600 MULLINIX MILL ROAD | MT AIRY | MD | 21771 |
| K091424 | OSTA TECHNOLOGIES |
845 ARONSON LAKE COURT | ROSWELL | GA | 30075 |
| K191737 | Purgo Biologics Inc. |
E-607, 700, Pangyo-ro | Seongnam-si | 13516 | |
| K230305 | Purgo Biologics Inc. |
#812, 27 Dunchon-daero 457beon-gil, Jungwon-gu | Seongnam-si | 13219 | |
| K173188 | Purgo Biologics Inc. |
E-607, 700, Pangyo-ro | Seongnam-si | 13516 | |
| K120152 | RIEMSER ARZNEIMITTEL AG |
5105 FAIROAKS RD. | DURHAM | NC | 27712 |
| K221808 | SigmaGraft Inc. |
575 Sally Place | Fullerton | CA | 92831 |
| K151209 | SigmaGraft, Inc |
335 N. Puente St. | Brea | CA | 92821 |
| K211551 | Wishbone SA |
1, Rue de 1'Expansion | Flemalle | 4400 |
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