The following data is part of a premarket notification filed by Precision Optics Corp. with the FDA for Poc Ent Endoscope - Sinuscope.
Device ID | K983123 |
510k Number | K983123 |
Device Name: | POC ENT ENDOSCOPE - SINUSCOPE |
Classification | Nasopharyngoscope (flexible Or Rigid) |
Applicant | PRECISION OPTICS CORP. 22 EAST BROADWAY Gardner, MA 01440 -3338 |
Contact | James Reilly |
Correspondent | James Reilly PRECISION OPTICS CORP. 22 EAST BROADWAY Gardner, MA 01440 -3338 |
Product Code | EOB |
CFR Regulation Number | 874.4760 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1998-07-01 |
Decision Date | 1998-09-25 |
Summary: | summary |