The following data is part of a premarket notification filed by John Wagner Associates, Inc. with the FDA for Grabber Warm Pack/mini Mini Heater/foot Heater.
Device ID | K880871 |
510k Number | K880871 |
Device Name: | GRABBER WARM PACK/MINI MINI HEATER/FOOT HEATER |
Classification | Pack, Hot Or Cold, Disposable |
Applicant | JOHN WAGNER ASSOCIATES, INC. 205 MASON CIRCLE P.O. BOX 4060 Concord, CA 94520 |
Contact | Erich Bussian |
Correspondent | Erich Bussian JOHN WAGNER ASSOCIATES, INC. 205 MASON CIRCLE P.O. BOX 4060 Concord, CA 94520 |
Product Code | IMD |
CFR Regulation Number | 890.5710 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-03-01 |
Decision Date | 1988-05-20 |