510(k) K833698

AMER. V. MUELLER SURG. STAPLES ILA by American Heyer Schulte — Product Code GDW

K833698 is an FDA 510(k) premarket notification submitted by American Heyer Schulte for the device "AMER. V. MUELLER SURG. STAPLES ILA". The FDA issued a decision of Substantially Equivalent on January 25, 1984. The device falls under product code GDW (Staple, Implantable), a Class II device regulated under 21 CFR 878.4750. American Heyer Schulte has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 25, 1984
Date Received
November 15, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Staple, Implantable
Device Class
Class II
Regulation Number
878.4750
Review Panel
SU
Submission Type