The following data is part of a premarket notification filed by Medical Engineering Laboratory, Inc. with the FDA for Tri Talon Retrieval Forceps.
Device ID | K973071 |
510k Number | K973071 |
Device Name: | TRI TALON RETRIEVAL FORCEPS |
Classification | Endoscopic Grasping/cutting Instrument, Non-powered |
Applicant | MEDICAL ENGINEERING LABORATORY, INC. 108 WEST WARREN ST., SUITE 207 Shelby, NC 28150 |
Contact | William J Young |
Correspondent | William J Young MEDICAL ENGINEERING LABORATORY, INC. 108 WEST WARREN ST., SUITE 207 Shelby, NC 28150 |
Product Code | OCZ |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1997-08-18 |
Decision Date | 1997-10-24 |