The following data is part of a premarket notification filed by Special Medical Co. Ltd. with the FDA for Specath Central Venous Catheter Kits.
| Device ID | K021130 |
| 510k Number | K021130 |
| Device Name: | SPECATH CENTRAL VENOUS CATHETER KITS |
| Classification | Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
| Applicant | SPECIAL MEDICAL CO. LTD. 55 Northern Blvd. Suite 200 Great Neck, NY 11021 |
| Contact | Susan D Goldstein-falk |
| Correspondent | Susan D Goldstein-falk SPECIAL MEDICAL CO. LTD. 55 Northern Blvd. Suite 200 Great Neck, NY 11021 |
| Product Code | FOZ |
| CFR Regulation Number | 880.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-04-09 |
| Decision Date | 2003-01-07 |
| Summary: | summary |