FDA 510(k) Applications for Medical Device:
Condom, Synthetic
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K070800 | ANSELL HEALTHCARE PRODUCTS LLC |
1635 INDUSTRIAL RD. | DOTHAN | AL | 36303 |
| K171172 | Ansell Healthcare Products LLC. |
111 Wood Avenue South, Suite 210 | Iselin | NJ | 08830 |
| K160399 | Ansell Healthcare Products, LLC |
111 Wood Avenue South, Suite 210 | Iselin | NJ | 08830 |
| K955672 | CARTER PRODUCTS |
HALF ACRE RD. | CRANBURY | NJ | 08512 |
| K240379 | Church & Dwight Co., Inc. |
469 North Harrison Streeet | Princeton | NJ | 08543 |
| K050828 | CHURCH & DWIGHT CO., INC. |
469 NORTH HARRISON STREET | PRINCETON | NJ | 08543 |
| K100767 | CHURCH & DWIGHT CO., INC. |
469 NORTH HARRISON STREET | PRINCETON | NJ | 08543 |
| K171639 | Church & Dwight Co., Inc. |
500 Charles Ewing Blvd. | Ewing | NJ | 08628 |
| K962816 | GENX INTL., INC. |
339 BARTLETT DR. | MADISON | CT | 06443 |
| K240896 | Global Protection Corp. |
12 Channel Street | Boston | MA | 02210 |
| K243967 | Global Protection Corp. |
12 Channel Street | Boston | MA | 02210 |
| K001974 | MAYER LABORATORIES |
646 KENNEDY ST., BLDG. C | OAKLAND | CA | 94606 |
| K203541 | Okamoto U.S.A. Inc. |
18 King Street | Stratford | CT | 06615 |
| K241617 | RB Health (US) LLC |
399 Interpace Parkway | Parsippany | NJ | 07054 |
| K974121 | SENSICON CORP. |
2595 COMMERCE WAY | VISTA | CA | 92083 |
| K971590 | SENSICON CORP. |
2595 COMMERCE WAY | VISTA | CA | 92083 |
| K072169 | SSL AMERICAS, INC. |
3585 ENGINEERING DR. | NORCROSS | GA | 30092 |
| K231908 | Suretex Limited |
31/1 Moo 4, Suratthani-Thakuapha Road | Tambon Khao Hua Kwai, Amphur Phunphin | 84130 | |
| K232470 | Suretex Limited |
31/1 Moo 4, Suratthani-Thakuapha Road | Suratthani | 84130 | |
| K182438 | Sxwell Usa LLC |
111 Wood Avenue South | Iselin | NJ | 08830 |
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