The following data is part of a premarket notification filed by Aesculap, Inc. with the FDA for Aesculap's Modular Endoscopic Instruments For Gynecology.
Device ID | K010752 |
510k Number | K010752 |
Device Name: | AESCULAP'S MODULAR ENDOSCOPIC INSTRUMENTS FOR GYNECOLOGY |
Classification | Coagulator-cutter, Endoscopic, Unipolar (and Accessories) |
Applicant | AESCULAP, INC. 3773 Corporate Parkway Center Valley, PA 18034 |
Contact | Leslie Young |
Correspondent | Leslie Young AESCULAP, INC. 3773 Corporate Parkway Center Valley, PA 18034 |
Product Code | KNF |
CFR Regulation Number | 884.4160 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2001-03-13 |
Decision Date | 2001-06-11 |