The following data is part of a premarket notification filed by Computer Motion, Inc. with the FDA for Aesop 3000 System And Accessories.
Device ID | K972699 |
510k Number | K972699 |
Device Name: | AESOP 3000 SYSTEM AND ACCESSORIES |
Classification | Laparoscope, General & Plastic Surgery |
Applicant | COMPUTER MOTION, INC. 130-B CREMONA DR. Goleta, CA 93117 |
Contact | Douglas P Bueschel |
Correspondent | Douglas P Bueschel COMPUTER MOTION, INC. 130-B CREMONA DR. Goleta, CA 93117 |
Product Code | GCJ |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1997-07-18 |
Decision Date | 1997-12-19 |
Summary: | summary |