510(k) K760847

FELDSTEIN BLEPHAROPLASTY CLIP SHARP P by V. Mueller O.V. Baxter Healthcare Corp. — Product Code HNC

K760847 is an FDA 510(k) premarket notification submitted by V. Mueller O.V. Baxter Healthcare Corp. for the device "FELDSTEIN BLEPHAROPLASTY CLIP SHARP P". The FDA issued a decision of Substantially Equivalent on November 2, 1976. The device falls under product code HNC (Specula, Ophthalmic), a Class I device regulated under 21 CFR 886.4350. V. Mueller O.V. Baxter Healthcare Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 2, 1976
Date Received
October 15, 1976
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Specula, Ophthalmic
Device Class
Class I
Regulation Number
886.4350
Review Panel
OP
Submission Type