The following data is part of a premarket notification filed by Ethicon Endo-surgery, Inc. with the FDA for Ethicon Endo Surgery Slotted Anoscope.
Device ID | K093896 |
510k Number | K093896 |
Device Name: | ETHICON ENDO SURGERY SLOTTED ANOSCOPE |
Classification | Anoscope And Accessories |
Applicant | ETHICON ENDO-SURGERY, INC. 4545 CREEK RD. Cincinnati, OH 45242 -2839 |
Contact | Glenda Marsh |
Correspondent | Glenda Marsh ETHICON ENDO-SURGERY, INC. 4545 CREEK RD. Cincinnati, OH 45242 -2839 |
Product Code | FER |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2009-12-18 |
Decision Date | 2010-03-25 |
Summary: | summary |