The following data is part of a premarket notification filed by Surgistar, Inc. with the FDA for Surgistar Trocars.
Device ID | K941747 |
510k Number | K941747 |
Device Name: | SURGISTAR TROCARS |
Classification | Laparoscope, General & Plastic Surgery |
Applicant | SURGISTAR, INC. P.O. BOX 2722 Vista, CA 92085 |
Contact | Jonathan Woodward |
Correspondent | Jonathan Woodward SURGISTAR, INC. P.O. BOX 2722 Vista, CA 92085 |
Product Code | GCJ |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-04-08 |
Decision Date | 1994-07-01 |