510(k) K910707
K910707 is an FDA 510(k) premarket notification submitted by Jedmed Instrument Co. for the device "OPERAID SURGICAL DRAIN W/ CORNEAL SHIELDS". The FDA issued a decision of Substantially Equivalent on April 10, 1991. The device falls under product code HOZ (Sponge, Ophthalmic), a Class II device regulated under 21 CFR 886.4790. Jedmed Instrument Co. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 10, 1991
- Date Received
- February 20, 1991
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Sponge, Ophthalmic
- Device Class
- Class II
- Regulation Number
- 886.4790
- Review Panel
- OP
- Submission Type