The following data is part of a premarket notification filed by 3nt Medical Ltd. with the FDA for Peregrine Endoscopy System.
Device ID | K202727 |
510k Number | K202727 |
Device Name: | Peregrine Endoscopy System |
Classification | Nasopharyngoscope (flexible Or Rigid) |
Applicant | 3NT Medical Ltd. 22 HaMelacha St., POB 11384 Rosh Ha'ayin, IL 4809169 |
Contact | Ehud Bendory |
Correspondent | Orly Maor Orly Maor 25A Sirkin Street Kfar Saba, IL 4442156 |
Product Code | EOB |
CFR Regulation Number | 874.4760 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2020-09-17 |
Decision Date | 2021-07-23 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
07290016539073 | K202727 | 000 |