510(k) K770222
K770222 is an FDA 510(k) premarket notification submitted by Concept, Inc. for the device "IRIS RETRACTOR". The FDA issued a decision of Substantially Equivalent on February 17, 1977. The device falls under product code HNI (Retractor, Ophthalmic), a Class I device regulated under 21 CFR 886.4350. Concept, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 17, 1977
- Date Received
- February 3, 1977
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Retractor, Ophthalmic
- Device Class
- Class I
- Regulation Number
- 886.4350
- Review Panel
- OP
- Submission Type