The following data is part of a premarket notification filed by Paladin Medical, Inc. with the FDA for Sharpe Endoscalpel.
| Device ID | K920548 |
| 510k Number | K920548 |
| Device Name: | SHARPE ENDOSCALPEL |
| Classification | Laparoscope, Gynecologic (and Accessories) |
| Applicant | PALADIN MEDICAL, INC. P.O. BOX 560 Stillwater, MN 55082 -0560 |
| Contact | Elaine Duncan |
| Correspondent | Elaine Duncan PALADIN MEDICAL, INC. P.O. BOX 560 Stillwater, MN 55082 -0560 |
| Product Code | HET |
| CFR Regulation Number | 884.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-02-06 |
| Decision Date | 1992-09-22 |