510(k) K880669

L-5 PLASTIC SURGERY CANNULAS by American Instrument Manufacturer'S, Inc. — Product Code GEA

K880669 is an FDA 510(k) premarket notification submitted by American Instrument Manufacturer'S, Inc. for the device "L-5 PLASTIC SURGERY CANNULAS". The FDA issued a decision of Substantially Equivalent on March 17, 1988. The device falls under product code GEA (Cannula, Surgical, General & Plastic Surgery), a Class I device regulated under 21 CFR 878.4800. American Instrument Manufacturer'S, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 17, 1988
Date Received
February 18, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cannula, Surgical, General & Plastic Surgery
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type