ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER MS5169
FDA 510(k) clearance K971099 · decided 1997-06-05
Clearance details
- K-number
- K971099
- Device name
- ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER MS5169
- Applicant
- Alexander Mfg. Co.
- Decision
- Substantially Equivalent
- Date received
- 1997-03-26
- Decision date
- 1997-06-05
- Days to decision
- 71 days
- Clearance type
- Traditional
- Product code
- HGM
- Device class
- 2
- Regulation number
- 884.2740
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Mason City, IA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.