The following data is part of a premarket notification filed by Computer Motion, Inc. with the FDA for Hermes Port Expander.
Device ID | K003217 |
510k Number | K003217 |
Device Name: | HERMES PORT EXPANDER |
Classification | Laparoscope, General & Plastic Surgery |
Applicant | COMPUTER MOTION, INC. 130 CREMONA DR., SUITE B Goleta, CA 93117 |
Contact | David U Thomas |
Correspondent | David U Thomas COMPUTER MOTION, INC. 130 CREMONA DR., SUITE B Goleta, CA 93117 |
Product Code | GCJ |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2000-10-13 |
Decision Date | 2000-11-03 |