The following data is part of a premarket notification filed by Medtech Products Ltd. with the FDA for Mighty Man (dynamic Linkers).
| Device ID | K993737 |
| 510k Number | K993737 |
| Device Name: | MIGHTY MAN (DYNAMIC LINKERS) |
| Classification | Condom |
| Applicant | MEDTECH PRODUCTS LTD. S-59 20TH ST., ANNA NAGAR WEST Chennai, IN 600 040 |
| Contact | A.v.k. Reddy |
| Correspondent | A.v.k. Reddy MEDTECH PRODUCTS LTD. S-59 20TH ST., ANNA NAGAR WEST Chennai, IN 600 040 |
| Product Code | HIS |
| CFR Regulation Number | 884.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-11-04 |
| Decision Date | 2000-03-20 |
| Summary: | summary |