The following data is part of a premarket notification filed by Sparta Surgical Corp. with the FDA for Microspears.
Device ID | K896084 |
510k Number | K896084 |
Device Name: | MICROSPEARS |
Classification | Sponge, Ophthalmic |
Applicant | SPARTA SURGICAL CORP. 26602 CORPORATE AVE. Hayward, CA 94545 |
Contact | Cindy Wilson |
Correspondent | Cindy Wilson SPARTA SURGICAL CORP. 26602 CORPORATE AVE. Hayward, CA 94545 |
Product Code | HOZ |
CFR Regulation Number | 886.4790 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-10-19 |
Decision Date | 1989-11-02 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
MICROSPEARS 73178804 1124453 Dead/Cancelled |
SPARTA INSTRUMENT CORPORATION 1978-07-19 |