SOFT-COVER— 510(k) K921928
Substantially EquivalentAdroit Medical Systems, Inc.
FDA 510(k) clearance K921928 for SOFT-COVER, Substantially Equivalent on 1992-11-06. Applicant: Adroit Medical Systems, Inc.. Device class: 1.
Clearance details
- Applicant
- Adroit Medical Systems, Inc.
- Product code
- Code FMW
- Device class
- Class 1
- Regulation
- 21 CFR 880.6190
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Morganton, NC, US
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