13L81 DISPOSABLE SPHINCTER ELECTRODE, 13L33 CABLE— 510(k) K874759
Substantially EquivalentDantec Electronics, Inc.
FDA 510(k) clearance K874759 for 13L81 DISPOSABLE SPHINCTER ELECTRODE, 13L33 CABLE, Substantially Equivalent on 1988-04-14. Applicant: Dantec Electronics, Inc.. Device class: 2.
Clearance details
- Applicant
- Dantec Electronics, Inc.
- Product code
- Code FAP
- Device class
- Class 2
- Regulation
- 21 CFR 876.1620
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Allendale, NJ, US
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