510(k) K781727

CHANGE IN STERILIZATION PROCEDURE by Absorbent Cotton Co., Inc. — Product Code GOY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 4, 1978
Date Received
October 11, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antisera, Agglutinating, B. Pertussis, All
Device Class
Class I
Regulation Number
866.3065
Review Panel
MI
Submission Type