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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 K812542
Device Name POLAROID INSTANT ENDOCAMERA
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 Received09/04/1981
Decision Date 10/19/1981
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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