The following data is part of a premarket notification filed by Parker Laboratories, Inc. with the FDA for Articulating Paper.
Device ID | K771011 |
510k Number | K771011 |
Device Name: | ARTICULATING PAPER |
Classification | Paper, Articulation |
Applicant | PARKER LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | EFH |
CFR Regulation Number | 872.6140 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1977-06-06 |
Decision Date | 1977-06-20 |