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 |