510(k) K010852
K010852 is an FDA 510(k) premarket notification submitted by Iop, Inc. for the device "OSMED TISSUE EXPANDER". The FDA issued a decision of Substantially Equivalent on August 13, 2001. The device falls under product code NFM (Expander, Tissue, Orbital), a Class II device regulated under 21 CFR 886.3320. Iop, Inc. has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 13, 2001
- Date Received
- March 21, 2001
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Expander, Tissue, Orbital
- Device Class
- Class II
- Regulation Number
- 886.3320
- Review Panel
- OP
- Submission Type