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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lavage, Jet
510(k) Number K820661
Device Name MICRO-AIRE DISPOSABLE MINI & MAXI LAVAG
Applicant
Micro-Aire Surgical Instruments, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Micro-Aire Surgical Instruments, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number880.5475
Classification Product Code
FQH  
Date Received03/10/1982
Decision Date 04/21/1982
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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