The following data is part of a premarket notification filed by P.a. Research Corp. with the FDA for Pullen Pocket Scope.
Device ID | K802818 |
510k Number | K802818 |
Device Name: | PULLEN POCKET SCOPE |
Classification | Light, Microscope |
Applicant | P.A. RESEARCH CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | IBJ |
CFR Regulation Number | 864.3600 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1980-11-07 |
Decision Date | 1981-04-17 |