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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Otoscope
510(k) Number K950787
Device Name WELCH ALLYN OTOSCOPE
Applicant
Welch Allyn, Inc.
4341 State St. Rd.
P.O. Box 220
Skaneateles Falls,  NY  13153 -0220
Applicant Contact CRAIG D MULLIN
Correspondent
Welch Allyn, Inc.
4341 State St. Rd.
P.O. Box 220
Skaneateles Falls,  NY  13153 -0220
Correspondent Contact CRAIG D MULLIN
Regulation Number874.4770
Classification Product Code
ERA  
Date Received02/21/1995
Decision Date 04/06/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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