DURADERM BUTTERFLY— 510(k) K881343
Substantially EquivalentSentry Medical Products, Inc.
FDA 510(k) clearance K881343 for DURADERM BUTTERFLY, Substantially Equivalent on 1988-05-04. Applicant: Sentry Medical Products, Inc.. Device class: 2.
Clearance details
- Applicant
- Sentry Medical Products, Inc.
- Product code
- Code GXY
- Device class
- Class 2
- Regulation
- 21 CFR 882.1320
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Santa Ana, CA, US
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