POUCH, TYVEK-POLYMYLON— 510(k) K770945
Substantially EquivalentMedical Disposables Intl., Inc.
FDA 510(k) clearance K770945 for POUCH, TYVEK-POLYMYLON, Substantially Equivalent on 1977-06-29. Applicant: Medical Disposables Intl., Inc.. Device class: 2.
Clearance details
- Applicant
- Medical Disposables Intl., Inc.
- Product code
- Code FPK
- Device class
- Class 2
- Regulation
- 21 CFR 880.5440
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
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