The following data is part of a premarket notification filed by Southwest Medical Mfg., Inc. with the FDA for Ever-sharp Biopsy Forceps.
| Device ID | K895303 |
| 510k Number | K895303 |
| Device Name: | EVER-SHARP BIOPSY FORCEPS |
| Classification | Forceps, Biopsy, Gynecological |
| Applicant | SOUTHWEST MEDICAL MFG., INC. P.O. BOX 71261 Marietta, GA 30007 |
| Contact | Mike Sibley |
| Correspondent | Mike Sibley SOUTHWEST MEDICAL MFG., INC. P.O. BOX 71261 Marietta, GA 30007 |
| Product Code | HFB |
| CFR Regulation Number | 884.4530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-08-29 |
| Decision Date | 1990-01-16 |