The following data is part of a premarket notification filed by Polaroid Corp. with the FDA for Polaroid Land Camera For Endoscopy.
Device ID | K792512 |
510k Number | K792512 |
Device Name: | POLAROID LAND CAMERA FOR ENDOSCOPY |
Classification | Accessories, Photographic, For Endoscope (exclude Light Sources) |
Applicant | POLAROID CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | FEM |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-12-05 |
Decision Date | 1979-12-20 |