The following data is part of a premarket notification filed by Suretex, Ltd. with the FDA for Condoms (rubber Contraceptives).
| Device ID | K910284 |
| 510k Number | K910284 |
| Device Name: | CONDOMS (RUBBER CONTRACEPTIVES) |
| Classification | Condom |
| Applicant | SURETEX, LTD. C/O G. PREMJEE (U.S.A.), INC. P.O. BOX 1084 Avondale, AZ 85323 |
| Contact | Anil Utamchandani |
| Correspondent | Anil Utamchandani SURETEX, LTD. C/O G. PREMJEE (U.S.A.), INC. P.O. BOX 1084 Avondale, AZ 85323 |
| Product Code | HIS |
| CFR Regulation Number | 884.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-01-23 |
| Decision Date | 1991-06-04 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 60761236901128 | K910284 | 000 |
| 00761236110184 | K910284 | 000 |
| 00761236110207 | K910284 | 000 |
| 00761236110214 | K910284 | 000 |
| 00761236110238 | K910284 | 000 |
| 00761236110245 | K910284 | 000 |
| 00761236110269 | K910284 | 000 |
| 00761236110276 | K910284 | 000 |
| 00761236110290 | K910284 | 000 |
| 60761236901074 | K910284 | 000 |
| 60761236901098 | K910284 | 000 |
| 00761236901119 | K910284 | 000 |
| 00761236110160 | K910284 | 000 |