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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name esophagoscope (flexible or rigid)
510(k) Number K951395
Device Name KARL STORZ ENT NEEDLES, TONSIL SYRINGES & NEEDLES
Applicant
KARL STORZ ENDOSCOPY-AMERICA, INC.
600 CORPORATE POINTE
CULVER CITY,  CA  90230 -7600
Applicant Contact RENATE A MACLAREN
Correspondent
KARL STORZ ENDOSCOPY-AMERICA, INC.
600 CORPORATE POINTE
CULVER CITY,  CA  90230 -7600
Correspondent Contact RENATE A MACLAREN
Regulation Number874.4710
Classification Product Code
EOX  
Subsequent Product Codes
EOB   EOQ   ERA  
Date Received03/28/1995
Decision Date 05/09/1995
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
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