ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER STR5— 510(k) K971107
Substantially EquivalentAlexander Mfg. Co.
FDA 510(k) clearance K971107 for ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER STR5, Substantially Equivalent on 1997-06-05. Applicant: Alexander Mfg. Co.. Device class: 2.
Clearance details
- Applicant
- Alexander Mfg. Co.
- Product code
- Code BTA
- Device class
- Class 2
- Regulation
- 21 CFR 878.4780
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mason City, IA, US
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Adverse events under product code BTA
product code BTA- Death
- 5
- Total
- 5
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.