The following data is part of a premarket notification filed by Amco International Manufacturing & Design, Inc. with the FDA for Life+cel Or Lifecel Battery Pack, Model 5l500.
| Device ID | K072596 |
| 510k Number | K072596 |
| Device Name: | LIFE+CEL OR LIFECEL BATTERY PACK, MODEL 5L500 |
| Classification | Batteries, Rechargeable, For Class 3 Devices |
| Applicant | AMCO INTERNATIONAL MANUFACTURING & DESIGN, INC. 377 ZANE CT. Elizabeth, CO 80107 |
| Contact | Alexander B Henderson |
| Correspondent | Alexander B Henderson AMCO INTERNATIONAL MANUFACTURING & DESIGN, INC. 377 ZANE CT. Elizabeth, CO 80107 |
| Product Code | MOY |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-09-14 |
| Decision Date | 2008-01-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00853258006009 | K072596 | 000 |