The following data is part of a premarket notification filed by Polaroid Corp. with the FDA for Polaroid Instant Endocamera.
Device ID | K812542 |
510k Number | K812542 |
Device Name: | POLAROID INSTANT ENDOCAMERA |
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 | 1981-09-04 |
Decision Date | 1981-10-19 |