The following data is part of a premarket notification filed by Sparco, Inc. with the FDA for Master-guard.
Device ID | K884041 |
510k Number | K884041 |
Device Name: | MASTER-GUARD |
Classification | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories |
Applicant | SPARCO, INC. 1930 WATSON WAY UNIT E Vista, CA 92083 |
Contact | J Sparks |
Correspondent | J Sparks SPARCO, INC. 1930 WATSON WAY UNIT E Vista, CA 92083 |
Product Code | KCT |
CFR Regulation Number | 880.6850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-09-26 |
Decision Date | 1988-10-07 |