The following data is part of a premarket notification filed by Johnson & Johnson Medical, Div. Of Ethicon, Inc. with the FDA for Modification Of Jelco*,jelco*-w And Jelco* Plus I.v. Catheters, Cathlon* I.v. Catheters, Optiva* I.v. Catheters, Protect.
| Device ID | K990236 |
| 510k Number | K990236 |
| Device Name: | MODIFICATION OF JELCO*,JELCO*-W AND JELCO* PLUS I.V. CATHETERS, CATHLON* I.V. CATHETERS, OPTIVA* I.V. CATHETERS, PROTECT |
| Classification | Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
| Applicant | JOHNSON & JOHNSON MEDICAL, DIV. OF ETHICON, INC. 2500 EAST ARBROOK BLVD. Arlington, TX 76014 -3631 |
| Contact | Linda G Hill |
| Correspondent | Linda G Hill JOHNSON & JOHNSON MEDICAL, DIV. OF ETHICON, INC. 2500 EAST ARBROOK BLVD. Arlington, TX 76014 -3631 |
| Product Code | FOZ |
| CFR Regulation Number | 880.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-01-25 |
| Decision Date | 1999-08-20 |
| Summary: | summary |