The following data is part of a premarket notification filed by Wells Johnson Co. with the FDA for Weco Endoscopic System With Fiber Optic Light.
Device ID | K951519 |
510k Number | K951519 |
Device Name: | WECO ENDOSCOPIC SYSTEM WITH FIBER OPTIC LIGHT |
Classification | Camera, Cine, Endoscopic, Without Audio |
Applicant | WELLS JOHNSON CO. 8075 E RESEARCH CT., STE. 101 P.O. BOX 18230 Tucson, AZ 85731 -8230 |
Contact | Brenda Hunt |
Correspondent | Brenda Hunt WELLS JOHNSON CO. 8075 E RESEARCH CT., STE. 101 P.O. BOX 18230 Tucson, AZ 85731 -8230 |
Product Code | FWL |
CFR Regulation Number | 878.4160 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-04-03 |
Decision Date | 1995-06-14 |