The following data is part of a premarket notification filed by Ethicon Endo-surgery, Inc. with the FDA for Modified Endopath Ils.
Device ID | K940967 |
510k Number | K940967 |
Device Name: | MODIFIED ENDOPATH ILS |
Classification | Endoscopic Tissue Approximation Device |
Applicant | ETHICON ENDO-SURGERY, INC. 4545 CREEK RD. Cincinnati, OH 45242 -2839 |
Contact | Lorri Jones |
Correspondent | Lorri Jones ETHICON ENDO-SURGERY, INC. 4545 CREEK RD. Cincinnati, OH 45242 -2839 |
Product Code | OCW |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-03-02 |
Decision Date | 1994-05-27 |