510(k) K881101

K ORTHOPEDIC TABLE by Instrumentation Specialties, Inc. — Product Code JEB

K881101 is an FDA 510(k) premarket notification submitted by Instrumentation Specialties, Inc. for the device "K ORTHOPEDIC TABLE". The FDA issued a decision of Substantially Equivalent on April 6, 1988. The device falls under product code JEB (Table, Surgical With Orthopedic Accessories, Manual), a Class I device regulated under 21 CFR 878.4950. Instrumentation Specialties, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 6, 1988
Date Received
March 15, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Table, Surgical With Orthopedic Accessories, Manual
Device Class
Class I
Regulation Number
878.4950
Review Panel
SU
Submission Type