510(k) K963305
- Device
- ALEXANDER BOX, BATTERY, RECHARGEABLE
- Applicant
- ALEXANDER MFG. CO.
- 510(k) number
- K963305
- Product code
- MOX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1997-04-17
- Date received
- 1996-08-22
- Regulation
- 510(k) Premarket Notification
- Classification name
- Batteries, Rechargeable, For Class 2 Devices
- Medical specialty
- 510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- STACEY HIPPEN
- Address
- 1511 S Garfield Pl. Mason City IA US 50401 50401
FDA Registration Numbers#
- 8030607
- 1836161
- 1923569
- 1219930
- 3001592626
- 1412854
- 3026612481
- 3018094310
Source Documents#
510(k) summary PDF not indicated by FDA
Legacy Summary#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases
FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases