The following data is part of a premarket notification filed by Applied Medical Technologies with the FDA for Biopsy Forceps (non-rigid).
Device ID | K901339 |
510k Number | K901339 |
Device Name: | BIOPSY FORCEPS (NON-RIGID) |
Classification | Instrument, Biopsy |
Applicant | APPLIED MEDICAL TECHNOLOGIES 6100 WEST CREEK RD. SUITE 25 Independence, OH 44131 |
Contact | Pat Gilpin |
Correspondent | Pat Gilpin APPLIED MEDICAL TECHNOLOGIES 6100 WEST CREEK RD. SUITE 25 Independence, OH 44131 |
Product Code | KNW |
CFR Regulation Number | 876.1075 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-03-22 |
Decision Date | 1990-06-11 |