The following data is part of a premarket notification filed by Reed Products, Inc. with the FDA for First Response Emerg. Medical System.
Device ID | K841897 |
510k Number | K841897 |
Device Name: | FIRST RESPONSE EMERG. MEDICAL SYSTEM |
Classification | Tape And Bandage, Adhesive |
Applicant | REED PRODUCTS, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | KGX |
CFR Regulation Number | 880.5240 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-05-07 |
Decision Date | 1984-07-23 |