The following data is part of a premarket notification filed by Snowden-pencer with the FDA for Diamond-sharp(r) Trocars.
| Device ID | K924148 |
| 510k Number | K924148 |
| Device Name: | DIAMOND-SHARP(R) TROCARS |
| Classification | Coagulator, Culdoscopic (and Accessories) |
| Applicant | SNOWDEN-PENCER 5175 SOUTH ROYAL ATLANTA DR. Tucker, GA 30084 |
| Contact | Julie A Stephens |
| Correspondent | Julie A Stephens SNOWDEN-PENCER 5175 SOUTH ROYAL ATLANTA DR. Tucker, GA 30084 |
| Product Code | HFI |
| CFR Regulation Number | 884.4160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-08-18 |
| Decision Date | 1994-02-28 |