The following data is part of a premarket notification filed by Mill-rose Laboratory with the FDA for Retrievable Forceps.
Device ID | K792345 |
510k Number | K792345 |
Device Name: | RETRIEVABLE FORCEPS |
Classification | Endoscopic Grasping/cutting Instrument, Non-powered |
Applicant | MILL-ROSE LABORATORY 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | OCZ |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-11-19 |
Decision Date | 1979-12-20 |