The following data is part of a premarket notification filed by Surgeon Surgical Instrumentation, Inc. with the FDA for Surgical Aspirator Kit.
Device ID | K904010 |
510k Number | K904010 |
Device Name: | SURGICAL ASPIRATOR KIT |
Classification | Instrument, Ultrasonic Surgical |
Applicant | SURGEON SURGICAL INSTRUMENTATION, INC. 1030 RICHFIELD RD. Placentia, CA 92670 |
Contact | Don W Haar |
Correspondent | Don W Haar SURGEON SURGICAL INSTRUMENTATION, INC. 1030 RICHFIELD RD. Placentia, CA 92670 |
Product Code | LFL |
CFR Regulation Number | 510(k) Premarket Notification [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-08-29 |
Decision Date | 1990-11-21 |