The following data is part of a premarket notification filed by Dowit Service Co., Inc. with the FDA for Battery Packs (other Than Cv).
Device ID | K881885 |
510k Number | K881885 |
Device Name: | BATTERY PACKS (OTHER THAN CV) |
Classification | Box, Battery, Pocket |
Applicant | DOWIT SERVICE CO., INC. 10 VALHALLA RD. Montville, NJ 07045 |
Contact | Joan Potosnak |
Correspondent | Joan Potosnak DOWIT SERVICE CO., INC. 10 VALHALLA RD. Montville, NJ 07045 |
Product Code | FCP |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-05-04 |
Decision Date | 1988-07-26 |