MARK IV HAND, THUMB AND WRIST (CPM) UNIT— 510(k) K894907
Substantially EquivalentInnovative Medical Engineering, Inc.
FDA 510(k) clearance K894907 for MARK IV HAND, THUMB AND WRIST (CPM) UNIT, Substantially Equivalent on 1989-10-06. Applicant: Innovative Medical Engineering, Inc.. Device class: 1.
Clearance details
- Applicant
- Innovative Medical Engineering, Inc.
- Product code
- Code BXB
- Device class
- Class 1
- Regulation
- 21 CFR 890.5380
- Advisory panel
- Physical Medicine
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Hawthorne, CA, US
Recent devices under product code BXB
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