510(k) K910707

OPERAID SURGICAL DRAIN W/ CORNEAL SHIELDS by Jedmed Instrument Co. — Product Code HOZ

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