510(k) K801469

BONN MICRO IRIS HOOK (NON-STERILE) #7613 by Edward Weck, Inc. — Product Code HNQ

K801469 is an FDA 510(k) premarket notification submitted by Edward Weck, Inc. for the device "BONN MICRO IRIS HOOK (NON-STERILE) #7613". The FDA issued a decision of Substantially Equivalent on July 28, 1980. The device falls under product code HNQ (Hook, Ophthalmic), a Class I device regulated under 21 CFR 886.4350. Edward Weck, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 28, 1980
Date Received
June 24, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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