The following data is part of a premarket notification filed by Surgical Instrument, Inc. with the FDA for Irrigation/suction Probe.
Device ID | K923667 |
510k Number | K923667 |
Device Name: | IRRIGATION/SUCTION PROBE |
Classification | Catheter, Irrigation |
Applicant | SURGICAL INSTRUMENT, INC. 1030 RICHFIELD RD. Placentia, CA 92670 |
Contact | Don W Haar |
Correspondent | Don W Haar SURGICAL INSTRUMENT, INC. 1030 RICHFIELD RD. Placentia, CA 92670 |
Product Code | GBX |
CFR Regulation Number | 878.4200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-07-22 |
Decision Date | 1993-04-23 |