DISPOSABLE APRON— 510(k) K964364
Substantially EquivalentInstrument Makar, Inc.
FDA 510(k) clearance K964364 for DISPOSABLE APRON, Substantially Equivalent on 1997-02-25. Applicant: Instrument Makar, Inc.. Device class: 1.
Clearance details
- Applicant
- Instrument Makar, Inc.
- Product code
- Code LYU
- Device class
- Class 1
- Regulation
- 21 CFR 878.4040
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Okemos, MI, US
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