510(k) K821648

GAS CHEX PLASTIC BAG by Propper Mfg. Co., Inc. — Product Code JOJ

K821648 is an FDA 510(k) premarket notification submitted by Propper Mfg. Co., Inc. for the device "GAS CHEX PLASTIC BAG". The FDA issued a decision of Substantially Equivalent on June 22, 1982. 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
June 22, 1982
Date Received
June 4, 1982
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