The following data is part of a premarket notification filed by Med-dex Intl. with the FDA for Utility Clamp.
| Device ID | K881084 |
| 510k Number | K881084 |
| Device Name: | UTILITY CLAMP |
| Classification | Clamp, Surgical, General & Plastic Surgery |
| Applicant | MED-DEX INTL. SUITE #237 4790 IRVINE BLVD. #105 Irvine, CA 92714 |
| Contact | Diane Momoda-madison |
| Correspondent | Diane Momoda-madison MED-DEX INTL. SUITE #237 4790 IRVINE BLVD. #105 Irvine, CA 92714 |
| Product Code | GDJ |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-03-14 |
| Decision Date | 1988-03-25 |