510(k) K834515

FIXATION STAPLE KIT - DLIDE HAMMER by Stryker Corp. — Product Code HXJ

K834515 is an FDA 510(k) premarket notification submitted by Stryker Corp. for the device "FIXATION STAPLE KIT - DLIDE HAMMER". The FDA issued a decision of Substantially Equivalent on April 23, 1984. The device falls under product code HXJ (Staple Driver), a Class I device regulated under 21 CFR 888.4540. Stryker Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 23, 1984
Date Received
December 21, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Staple Driver
Device Class
Class I
Regulation Number
888.4540
Review Panel
OR
Submission Type