The following data is part of a premarket notification filed by Sparta Instrument Corp. with the FDA for Microspears.
Device ID | K780257 |
510k Number | K780257 |
Device Name: | MICROSPEARS |
Classification | Sponge, Ophthalmic |
Applicant | SPARTA INSTRUMENT CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | HOZ |
CFR Regulation Number | 886.4790 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1978-02-15 |
Decision Date | 1978-02-23 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
MICROSPEARS 73178804 1124453 Dead/Cancelled |
SPARTA INSTRUMENT CORPORATION 1978-07-19 |