The following data is part of a premarket notification filed by Critikon Company,llc with the FDA for Changes To Protectiv(tm) & Jelco(tm) Winged Cath.
| Device ID | K933050 |
| 510k Number | K933050 |
| Device Name: | CHANGES TO PROTECTIV(TM) & JELCO(TM) WINGED CATH |
| Classification | Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
| Applicant | CRITIKON COMPANY,LLC 4110 GEORGE RD. P.O. BOX 31800 Tampa, FL 33631 -3800 |
| Contact | John S Samorajczyk |
| Correspondent | John S Samorajczyk CRITIKON COMPANY,LLC 4110 GEORGE RD. P.O. BOX 31800 Tampa, FL 33631 -3800 |
| Product Code | FOZ |
| CFR Regulation Number | 880.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-05-20 |
| Decision Date | 1993-12-14 |