INSULATED THERMOELASTOMER MITT— 510(k) K823622
Substantially EquivalentFred Sammons, Inc.
FDA 510(k) clearance K823622 for INSULATED THERMOELASTOMER MITT, Substantially Equivalent on 1982-12-30. Applicant: Fred Sammons, Inc.. Device class: 1.
Clearance details
- Applicant
- Fred Sammons, Inc.
- Product code
- Code IMA
- Device class
- Class 1
- Regulation
- 21 CFR 890.5730
- Advisory panel
- Physical Medicine
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Walker, MI, US
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