The following data is part of a premarket notification filed by Numed Technologies, Inc. with the FDA for Mallawany Atraumatic Tissue Forceps.
| Device ID | K922248 |
| 510k Number | K922248 |
| Device Name: | MALLAWANY ATRAUMATIC TISSUE FORCEPS |
| Classification | Laparoscope, Gynecologic (and Accessories) |
| Applicant | NUMED TECHNOLOGIES, INC. 5755 GRANGER RD. Independence, OH 44131 |
| Contact | Jan J Lewandowski |
| Correspondent | Jan J Lewandowski NUMED TECHNOLOGIES, INC. 5755 GRANGER RD. Independence, OH 44131 |
| Product Code | HET |
| CFR Regulation Number | 884.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-05-13 |
| Decision Date | 1994-02-17 |