The following data is part of a premarket notification filed by Ethicon, Inc. with the FDA for Cannula.
Device ID | K843187 |
510k Number | K843187 |
Device Name: | CANNULA |
Classification | Cannula, Surgical, General & Plastic Surgery |
Applicant | ETHICON, INC. P.O BOX 151, ROUTE 22 WEST Somerville, NJ 08876 |
Contact | Robert H O'holla |
Correspondent | Robert H O'holla ETHICON, INC. P.O BOX 151, ROUTE 22 WEST Somerville, NJ 08876 |
Product Code | GEA |
CFR Regulation Number | 878.4800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-08-13 |
Decision Date | 1984-10-31 |