The following data is part of a premarket notification filed by Fraass Survival Systems, Inc. with the FDA for Kit, First Aid, General Purpose, Rigid Case.
Device ID | K871501 |
510k Number | K871501 |
Device Name: | KIT, FIRST AID, GENERAL PURPOSE, RIGID CASE |
Classification | First Aid Kit With Drug |
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 | LRR |
CFR Regulation Number | 510(k) Premarket Notification [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-04-17 |
Decision Date | 1987-06-02 |