510(k) K930028

CALMPS: BONE, MASTIN, LEWIN, BRAND by Thomasville Medical Assoc. — Product Code LXH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 16, 1993
Date Received
January 5, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Orthopedic Manual Surgical Instrument
Device Class
Class I
Regulation Number
888.4540
Review Panel
OR
Submission Type