The following data is part of a premarket notification filed by Schoelly Fiberoptic Gmbh with the FDA for Schoelly Sinuscope.
Device ID | K142249 |
510k Number | K142249 |
Device Name: | SCHOELLY SINUSCOPE |
Classification | Nasopharyngoscope (flexible Or Rigid) |
Applicant | SCHOELLY FIBEROPTIC GMBH ROBERT-BOSCH-STR. 1-3 Denzlingen, DE D-79211 |
Contact | Sandra Baumann |
Correspondent | Pamela Papineau DELPHI MEDICAL DEVICE CONSULTING, INC. 5 WHITCOMB AVE Ayer, MA 01432 |
Product Code | EOB |
CFR Regulation Number | 874.4760 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-08-14 |
Decision Date | 2015-01-27 |
Summary: | summary |