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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Sterilizer, Dry Heat
510(k) Number K771070
Device Name DRY HEAT STERILIZER
Applicant
CPAC, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
CPAC, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number880.6870
Classification Product Code
KMH  
Date Received06/14/1977
Decision Date 07/14/1977
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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