The following data is part of a premarket notification filed by Intl. Medical Devices Ltd. with the FDA for Nu-cath Emergency Kit.
| Device ID | K850398 |
| 510k Number | K850398 |
| Device Name: | NU-CATH EMERGENCY KIT |
| Classification | Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
| Applicant | INTL. MEDICAL DEVICES LTD. 2049 CENTURY PARK EAST SUITE 1200, TWO CENTURY PLAZA Los Angeles, CA 90067 |
| Contact | Jay H Geller |
| Correspondent | Jay H Geller INTL. MEDICAL DEVICES LTD. 2049 CENTURY PARK EAST SUITE 1200, TWO CENTURY PLAZA Los Angeles, CA 90067 |
| Product Code | FOZ |
| CFR Regulation Number | 880.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-02-01 |
| Decision Date | 1985-03-27 |