The following data is part of a premarket notification filed by Pilling Co. with the FDA for Fiberbronchoscope (pentax Fb-17a).
Device ID | K760171 |
510k Number | K760171 |
Device Name: | FIBERBRONCHOSCOPE (PENTAX FB-17A) |
Classification | Bronchoscope (flexible Or Rigid) |
Applicant | PILLING CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | EOQ |
CFR Regulation Number | 874.4680 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1976-07-06 |
Decision Date | 1976-07-19 |