SPONGE COUNT— 510(k) K945144
Substantially EquivalentMichael Fischer Assoc.
FDA 510(k) clearance K945144 for SPONGE COUNT, Substantially Equivalent on 1995-01-12. Applicant: Michael Fischer Assoc.. Device class: 1.
Clearance details
- Applicant
- Michael Fischer Assoc.
- Product code
- Code LWH
- Device class
- Class 1
- Regulation
- 21 CFR 880.2740
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Winnetka, IL, US
Recent devices under product code LWH
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