The following data is part of a premarket notification filed by Medical Creative Technologies, Inc. with the FDA for K&w 2-piece Take-apart Instruments(various).
Device ID | K973259 |
510k Number | K973259 |
Device Name: | K&W 2-PIECE TAKE-APART INSTRUMENTS(VARIOUS) |
Classification | Endoscopic Grasping/cutting Instrument, Non-powered |
Applicant | MEDICAL CREATIVE TECHNOLOGIES, INC. 2950-N ADVANCE LN. Colmar, PA 18915 -9727 |
Contact | Perk Crook |
Correspondent | Perk Crook MEDICAL CREATIVE TECHNOLOGIES, INC. 2950-N ADVANCE LN. Colmar, PA 18915 -9727 |
Product Code | OCZ |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1997-08-29 |
Decision Date | 1997-09-10 |
Summary: | summary |