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 |