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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Syringe, Irrigating (Non Dental)
510(k) Number K884786
Device Name EAR IRRIGATION SET 101 (EARIGATOR)
Applicant
Physicians Supply Co.
2963 E. Fallentine Rd.
Sandy,  UT  84092
Applicant Contact DIEHL, M.D.
Correspondent
Physicians Supply Co.
2963 E. Fallentine Rd.
Sandy,  UT  84092
Correspondent Contact DIEHL, M.D.
Regulation Number880.6960
Classification Product Code
KYZ  
Date Received11/15/1988
Decision Date 04/26/1989
Decision Substantially Equivalent - With Drug (SESD)
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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