The following data is part of a premarket notification filed by Medical Perspectives Corp. with the FDA for Triangular Sponges.
| Device ID | K953088 |
| 510k Number | K953088 |
| Device Name: | TRIANGULAR SPONGES |
| Classification | Gauze/sponge, Internal, X-ray Detectable |
| Applicant | MEDICAL PERSPECTIVES CORP. 50 AIKEN ST. UNIT 213 Norwalk, CT 06851 |
| Contact | David M Pieratos |
| Correspondent | David M Pieratos MEDICAL PERSPECTIVES CORP. 50 AIKEN ST. UNIT 213 Norwalk, CT 06851 |
| Product Code | GDY |
| CFR Regulation Number | 878.4450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-07-03 |
| Decision Date | 1995-09-14 |