510(k) K961156

ONCE-A-DAY BOWIE AND DICK TEST PACK. by Propper Mfg. Co., Inc. — Product Code JOJ

K961156 is an FDA 510(k) premarket notification submitted by Propper Mfg. Co., Inc. for the device "ONCE-A-DAY BOWIE AND DICK TEST PACK.". The FDA issued a decision of Substantially Equivalent on April 1, 1997. The device falls under product code JOJ (Indicator, Physical/Chemical Sterilization Process), a Class II device regulated under 21 CFR 880.2800. Propper Mfg. Co., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 1, 1997
Date Received
March 22, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Indicator, Physical/Chemical Sterilization Process
Device Class
Class II
Regulation Number
880.2800
Review Panel
HO
Submission Type