The following data is part of a premarket notification filed by Alexander Mfg. Co. with the FDA for Alexander Manufacturing Company Prchargeable Battery.
Device ID | K970268 |
510k Number | K970268 |
Device Name: | ALEXANDER MANUFACTURING COMPANY PRCHARGEABLE BATTERY |
Classification | Ophthalmoscopes, Replacement Batteries, Hand-held |
Applicant | ALEXANDER MFG. CO. 1511 S GARFIELD PL Mason City, IA 50401 |
Contact | Stacey Hippen |
Correspondent | Stacey Hippen ALEXANDER MFG. CO. 1511 S GARFIELD PL Mason City, IA 50401 |
Product Code | MSG |
CFR Regulation Number | 886.1570 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1997-01-23 |
Decision Date | 1997-03-31 |