FDA 510(k) Applications for Medical Device:
Dura Substitute
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K153613 | ACERA SURGICAL, INC. |
10880 BAUR BLVD. | ST. LOUIS | MO | 63132 |
| K161278 | ACERA SURGICAL, INC. |
10880 BAUR BLVD. | ST. LOUIS | MO | 63132 |
| K172603 | Acera Surgical, Inc. |
10880 Baur Blvd. | St. Louis | MO | 63132 |
| K970851 | AESCULAP, INC. |
1000 GATEWAY BLVD. | SOUTH SAN FRANCISCO | CA | 94080 |
| K122791 | AESCULAP, INC. |
3773 Corporate Parkway | Center Valley | PA | 18034 |
| K960470 | AESCULAP, INC. |
1000 GATEWAY BLVD. | SOUTH SAN FRANCISCO | CA | 94080 |
| K982282 | BIO-VASCULAR, INC. |
2575 UNIVERSITY AVE. | ST. PAUL | MN | 55114-1024 |
| K973706 | BIO-VASCULAR, INC. |
2575 UNIVERSITY AVE. | ST. PAUL | MN | 55114-1024 |
| K980548 | BRIDGER BIOMED, INC. |
2430 NORTH 7TH AVE., SUITE 4 | BOZEMAN | MT | 59715 |
| K041518 | Codman & Shurtleff, Inc. |
325 PARAMOUNT DR. | RAYNHAM | MA | 02767-0350 |
| K152481 | CODMAN & SHURTLEFF, INC. |
325 PARAMOUNT DRIVE | RAYNHAM | MA | 02767 |
| K141608 | COLLAGEN MATRIX, INC. |
15 THORNTON ROAD | OAKLAND | NJ | 07436 |
| K150825 | COLLAGEN MATRIX, INC. |
15 THORNTON ROAD | OAKLAND | NJ | 07436 |
| K040888 | COLLAGEN MATRIX, INC. |
509 COMMERCE ST. | FRANKLIN LAKES, | NJ | 07417 |
| K061487 | COLLAGEN MATRIX, INC. |
509 COMMERCE ST. | FRANKLIN LAKES, | NJ | 07417 |
| K131015 | COOK BIOTECH, INC. |
1425 INNOVATION PLACE | WEST LAFAYETTE | IN | 47906 |
| K031850 | COOK BIOTECH, INC. |
3055 KENT AVE. | WEST LAFAYETTE | IN | 47906-1076 |
| K120600 | INTEGRA LIFESCIENCES |
311 ENTERPRISE DR. | PLAINSBORO | NJ | 08536 |
| K982180 | INTEGRA LIFESCIENCES CORP. |
105 MORGAN LANE | PLAINSBORO | NJ | 08536 |
| K043427 | INTEGRA LIFESCIENCES CORP. |
105 MORGAN LANE | PLAINSBORO | NJ | 08536 |
| K032693 | INTEGRA LIFESCIENCES CORP. |
311 ENTERPRISE DR. | PLAINSBORO | NJ | 08536 |
| K072207 | INTEGRA LIFESCIENCES CORP. |
311C ENTERPRISE DRIVE | PLAINSBORO | NJ | 08536 |
| K092388 | INTEGRA LIFESCIENCES CORPORATION |
311 ENTERPRISE DR. | PLAINSBORO | NJ | 08536 |
| K163456 | INTEGRA LIFESCIENCES CORPORATION |
311 ENTERPRISE DRIVE | PLAINSBORO | NJ | 08536 |
| K991413 | JOHNSON & JOHNSON PROFESSIONALS, INC. |
325 PARAMOUNT DR. | RAYNHAM | MA | 02767 |
| K183513 | LeMaitre Vascular Inc. |
63 Second Ave | Burlington | MA | 01803 |
| K061208 | LIFECELL CORP. |
ONE MILLENIUM WAY | BRANCHBURG | NJ | 08876 |
| K052211 | MEDTRONIC NEUROSURGERY |
125 CREMONA DR. | GOLETA | CA | 93117 |
| K041000 | MEDTRONIC NEUROSURGERY |
125 CREMONA DR., | GOLETA | CA | 93117 |
| K161370 | Medtronic Neurosurgery |
125 Cremona Drive | Goleta | CA | 93117 |
| K063117 | MEDTRONIC NEUROSURGERY |
125 CREMONA DR. | GOLETA | CA | 93117 |
| K223445 | Nurami Medical Ltd. |
Ha'Namal 36 | Haifa | 3303203 | |
| K132850 | RTI SURGICAL, INC. |
11621 Research Cir | ALACHUA | FL | 32615 |
| K982101 | SHELHIGH, INC. |
P.O. BOX 884 | MILLBURN | NJ | 07041 |
| K113071 | SYNTHES |
1301 Goshen Parkway | West Chester | PA | 19380 |
| K212943 | Synthes (USA) products, LLC |
1230 Wilson Dr. | West Chester | PA | 19380 |
| K131792 | SYNTHES INC |
1301 Goshen Parkway | West Chester | PA | 19380 |
| K021477 | W. L. GORE & ASSOCIATES, INC. |
3450 WEST KILTIE LN. | FLAGSTAFF | AZ | 86001 |
| K984534 | W.L. GORE & ASSOCIATES,INC |
301 AIRPORT RD | ELKTON | MD | 21922-1408 |
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