OSMED TISSUE EXPANDER— 510(k) K010852
Substantially EquivalentIop, Inc.
FDA 510(k) clearance K010852 for OSMED TISSUE EXPANDER, Substantially Equivalent on 2001-08-13. Applicant: Iop, Inc.. Device class: 2.
Clearance details
- Applicant
- Iop, Inc.
- Product code
- Code NFM
- Device class
- Class 2
- Regulation
- 21 CFR 886.3320
- Advisory panel
- Ophthalmic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Costa Mesa, CA, US
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