The following data is part of a premarket notification filed by Surgistar, Inc. with the FDA for Surgistar Blades.
Device ID | K923689 |
510k Number | K923689 |
Device Name: | SURGISTAR BLADES |
Classification | Scalpel, One-piece |
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 | GDX |
CFR Regulation Number | 878.4800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-07-24 |
Decision Date | 1992-09-09 |