The following data is part of a premarket notification filed by Fraass Survival Systems, Inc. with the FDA for Survival Kit, Individual.
Device ID | K871437 |
510k Number | K871437 |
Device Name: | SURVIVAL KIT, INDIVIDUAL |
Classification | General Surgery Tray |
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 | LRO |
CFR Regulation Number | 878.4370 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-04-13 |
Decision Date | 1987-07-09 |