The following data is part of a premarket notification filed by Alexander Mfg. Co. with the FDA for Alexander Manufacturing Co. Rechargeable Battery Part Number Lp9.
Device ID | K982896 |
510k Number | K982896 |
Device Name: | ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER LP9 |
Classification | Dc-defibrillator, Low-energy, (including Paddles) |
Applicant | ALEXANDER MFG. CO. 1511 S GARFIELD PL Mason City, IA 50401 |
Contact | Ken Heimendinger |
Correspondent | Ken Heimendinger ALEXANDER MFG. CO. 1511 S GARFIELD PL Mason City, IA 50401 |
Product Code | LDD |
CFR Regulation Number | 870.5300 [🔎] |
Decision | Se Subject To Tracking Reg (ST) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1998-08-17 |
Decision Date | 1998-10-21 |