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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Accessories, Photographic, For Endoscope (Exclude Light Sources)
510(k) Number K792512
Device Name POLAROID LAND CAMERA FOR ENDOSCOPY
Applicant
Polaroid Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Polaroid Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number876.1500
Classification Product Code
FEM  
Date Received12/05/1979
Decision Date 12/20/1979
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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