The following data is part of a premarket notification filed by Fraass Survival Systems, Inc. with the FDA for Compress And Skullcap, Head Dressing.
Device ID | K870240 |
510k Number | K870240 |
Device Name: | COMPRESS AND SKULLCAP, HEAD DRESSING |
Classification | Urinometer, Mechanical |
Applicant | FRAASS SURVIVAL SYSTEMS, INC. 3830 BOSTON RD. Bronx, NY 10475 |
Contact | Patrick A Malia |
Correspondent | Patrick A Malia FRAASS SURVIVAL SYSTEMS, INC. 3830 BOSTON RD. Bronx, NY 10475 |
Product Code | EXR |
CFR Regulation Number | 876.1800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-01-21 |
Decision Date | 1987-02-20 |