The following data is part of a premarket notification filed by Pitango Medical Ltd with the FDA for Comcaset Safety Iv Catheter.
| Device ID | K062108 |
| 510k Number | K062108 |
| Device Name: | COMCASET SAFETY IV CATHETER |
| Classification | Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
| Applicant | PITANGO MEDICAL LTD 3A JABOTINSKI ST, 28TH FLOOR DIAMOND HOUSE-DORON LEVY Ramat Gan, IL 52520 |
| Contact | Ben Levin |
| Correspondent | Patricia L Murphy KEMA QUALITY B.V. 4377 COUNTY LINE ROAD Chalfont, PA 18914 |
| Product Code | FOZ |
| CFR Regulation Number | 880.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2006-07-24 |
| Decision Date | 2006-08-08 |
| Summary: | summary |