The following data is part of a premarket notification filed by Sparco, Inc. with the FDA for Flash Guard Plastic Version.
Device ID | K844286 |
510k Number | K844286 |
Device Name: | FLASH GUARD PLASTIC VERSION |
Classification | Tray, Surgical, Instrument |
Applicant | SPARCO, INC. P.O. BOX 20369 Castro Valley, CA 94546 |
Contact | Beverly J Sparks |
Correspondent | Beverly J Sparks SPARCO, INC. P.O. BOX 20369 Castro Valley, CA 94546 |
Product Code | FSM |
CFR Regulation Number | 878.4800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-11-05 |
Decision Date | 1984-11-19 |