510(k) K910621

BLADES FOR SPINAL LAMINECTOMY RETRACTOR by International Hospital Supply Co. — Product Code GZT

K910621 is an FDA 510(k) premarket notification submitted by International Hospital Supply Co. for the device "BLADES FOR SPINAL LAMINECTOMY RETRACTOR". The FDA issued a decision of Substantially Equivalent on Apr 1, 1991. The device falls under product code GZT (Retractor, Self-Retaining, For Neurosurgery), a Class II device regulated under 21 CFR 882.4800. International Hospital Supply Co. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Apr 1, 1991
Date Received
Feb 12, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Retractor, Self-Retaining, For Neurosurgery
Device Class
Class II
Regulation Number
882.4800
Review Panel
NE
Submission Type