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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Accessory, Surgical Apparel
510(k) Number K942828
Device Name MAKAR FULL AND HALF FACE SHIELD
Applicant
Instrument Makar, Inc.
2950 E. Mt. Hope Rd.
Okemos,  MI  48864
Applicant Contact JEANNIE M CLEARY
Correspondent
Instrument Makar, Inc.
2950 E. Mt. Hope Rd.
Okemos,  MI  48864
Correspondent Contact JEANNIE M CLEARY
Regulation Number878.4040
Classification Product Code
LYU  
Date Received06/14/1994
Decision Date 02/23/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
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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