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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
510(k) Number K781699
Device Name EAGLE PAC/VISIBLE SEAL
Applicant
American Sterilizer Co.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
American Sterilizer Co.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number880.6850
Classification Product Code
KCT  
Date Received10/11/1978
Decision Date 10/24/1978
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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