BURKE CONGENITAL THORACOSCOPY INSTRUMENTS— 510(k) K962771
Substantially EquivalentPilling Weck, Inc.
FDA 510(k) clearance K962771 for BURKE CONGENITAL THORACOSCOPY INSTRUMENTS, Substantially Equivalent on 1996-11-19. Applicant: Pilling Weck, Inc.. Device class: 1.
Clearance details
- Applicant
- Pilling Weck, Inc.
- Product code
- Code DWS
- Device class
- Class 1
- Regulation
- 21 CFR 870.4500
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Fort Washington, PA, US
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