The following data is part of a premarket notification filed by Ethicon Endo-surgery, Inc. with the FDA for Endopouch Retriever.
Device ID | K011501 |
510k Number | K011501 |
Device Name: | ENDOPOUCH RETRIEVER |
Classification | Laparoscope, General & Plastic Surgery |
Applicant | ETHICON ENDO-SURGERY, INC. 4545 CREEK RD. Cincinnati, OH 45242 -2839 |
Contact | Doug Kentz |
Correspondent | Doug Kentz ETHICON ENDO-SURGERY, INC. 4545 CREEK RD. Cincinnati, OH 45242 -2839 |
Product Code | GCJ |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2001-05-16 |
Decision Date | 2001-07-19 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
ENDOPOUCH RETRIEVER 76274492 2765036 Live/Registered |
JOHNSON & JOHNSON 2001-06-21 |