The following data is part of a premarket notification filed by Reddy Medtech Health Products Ltd. with the FDA for Htl Male Condom.
| Device ID | K980019 |
| 510k Number | K980019 |
| Device Name: | HTL MALE CONDOM |
| Classification | Condom |
| Applicant | REDDY MEDTECH HEALTH PRODUCTS LTD. S-59, 20TH ST. ANNANAGAR WEST Chennai, IN 600 040 |
| Contact | A.v.k. Reddy |
| Correspondent | A.v.k. Reddy REDDY MEDTECH HEALTH PRODUCTS LTD. S-59, 20TH ST. ANNANAGAR WEST Chennai, IN 600 040 |
| Product Code | HIS |
| CFR Regulation Number | 884.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-01-02 |
| Decision Date | 1998-04-01 |