The following data is part of a premarket notification filed by Hindustan Latex Ltd. with the FDA for Condoms, Moods/share & Rakshak.
| Device ID | K910470 |
| 510k Number | K910470 |
| Device Name: | CONDOMS, MOODS/SHARE & RAKSHAK |
| Classification | Condom |
| Applicant | HINDUSTAN LATEX LTD. 3030 ANTLER DR. Doylestown, PA 18901 |
| Contact | James R Collie |
| Correspondent | James R Collie HINDUSTAN LATEX LTD. 3030 ANTLER DR. Doylestown, PA 18901 |
| Product Code | HIS |
| CFR Regulation Number | 884.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-02-04 |
| Decision Date | 1991-12-18 |