510(k) K921229

STERILE/SINGLE USE OPHTHALMIC CONFORMERS by Storz Instrument Co. — Product Code HQN

K921229 is an FDA 510(k) premarket notification submitted by Storz Instrument Co. for the device "STERILE/SINGLE USE OPHTHALMIC CONFORMERS". The FDA issued a decision of Substantially Equivalent on June 9, 1992. The device falls under product code HQN (Conformer, Ophthalmic), a Class II device regulated under 21 CFR 886.3130. Storz Instrument Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 9, 1992
Date Received
March 13, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Conformer, Ophthalmic
Device Class
Class II
Regulation Number
886.3130
Review Panel
OP
Submission Type