510(k) K792633

STERILIZATION PROCESS/OUTERWRAP by Procter & Gamble Mfg. Co. — Product Code KET

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 11, 1980
Date Received
December 19, 1979
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Filters, Cell Collection, Tissue Processing
Device Class
Class I
Regulation Number
864.3010
Review Panel
PA
Submission Type