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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Indicator, Physical/Chemical Sterilization Process
510(k) Number K821648
Device Name GAS CHEX PLASTIC BAG
Applicant
Propper Mfg. Co., Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Propper Mfg. Co., Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number880.2800
Classification Product Code
JOJ  
Date Received06/04/1982
Decision Date 06/22/1982
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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