510(k) K971108
- Device
- ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER MS721-P
- Applicant
- ALEXANDER MFG. CO.
- 510(k) number
- K971108
- Product code
- MSG
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1997-05-06
- Date received
- 1997-03-26
- Regulation
- 886.1570
- Classification name
- Ophthalmoscopes, Replacement Batteries, Hand-held
- Medical specialty
- Ophthalmic
- Review panel
- Ophthalmic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- KEN HEIMENDINGER
- Address
- 1511 S Garfield Pl. Mason City IA US 50401 50401
FDA Registration Numbers#
- 3013436538
- 3006550126
- 3011898560
- 3004095901
- 3015512299
- 3002761766
- 3027187888
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code MSG #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K970268 | ALEXANDER MANUFACTURING COMPANY PRCHARGEABLE BATTERY | Alexander Mfg. Co. | 1997-03-31 |
Legacy Summary#
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FDA Review#
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