The following data is part of a premarket notification filed by Microaire Advanced Surgical Products with the FDA for Fiber Optic Univeral Cables, Scope Adap., Lt.sourc.
Device ID | K912767 |
510k Number | K912767 |
Device Name: | FIBER OPTIC UNIVERAL CABLES, SCOPE ADAP., LT.SOURC |
Classification | Source, Carrier, Fiberoptic Light |
Applicant | MICROAIRE ADVANCED SURGICAL PRODUCTS 24907 AVENUE TIBBETTS UNIT A Valencia, CA 91355 |
Contact | Siddharth Desai |
Correspondent | Siddharth Desai MICROAIRE ADVANCED SURGICAL PRODUCTS 24907 AVENUE TIBBETTS UNIT A Valencia, CA 91355 |
Product Code | EQH |
CFR Regulation Number | 874.4350 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-06-24 |
Decision Date | 1991-08-13 |