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U.S. Department of Health and Human Services

510(k) Premarket Notification

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510(k) Number K822804
Device Name OPERATING ROOM PROCEDURAL PACK
Applicant
Adicon
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Adicon
4221 Richmond Rd., NW
Walker,  MI  49534
Date Received09/17/1982
Decision Date 12/28/1982
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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