The following data is part of a premarket notification filed by Ethicon Inc. with the FDA for Endoscopic Applicator.
Device ID | K051732 |
510k Number | K051732 |
Device Name: | ENDOSCOPIC APPLICATOR |
Classification | Laparoscope, General & Plastic Surgery |
Applicant | ETHICON INC. ROUTE 22 WEST Somerville, NJ 08876 |
Contact | Peter Cecchini |
Correspondent | Peter Cecchini ETHICON INC. ROUTE 22 WEST Somerville, NJ 08876 |
Product Code | GCJ |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2005-06-28 |
Decision Date | 2005-08-09 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
20705031131955 | K051732 | 000 |