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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name probe, ent
510(k) Number K822277
Device Name ROSEN'S STAPES NEEDLE EXPLORER
Applicant
KELLEHER CORP.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
KELLEHER CORP.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number874.4420
Classification Product Code
KAK  
Date Received07/29/1982
Decision Date 08/25/1982
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
Recalls CDRH Recalls
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