The following data is part of a premarket notification filed by United Medical Systems, Inc. with the FDA for Tocolytic Site Care Sup Kit #1001/100a/carry Case.
| Device ID | K893003 |
| 510k Number | K893003 |
| Device Name: | TOCOLYTIC SITE CARE SUP KIT #1001/100A/CARRY CASE |
| Classification | Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
| Applicant | UNITED MEDICAL SYSTEMS, INC. 1901 E. CARNEGIE AVE. Santa Ana, CA 92705 |
| Contact | Gabrel Deutsch |
| Correspondent | Gabrel Deutsch UNITED MEDICAL SYSTEMS, INC. 1901 E. CARNEGIE AVE. Santa Ana, CA 92705 |
| Product Code | FOZ |
| CFR Regulation Number | 880.5200 [🔎] |
| Decision | Substantially Equivalent - With Drug (SESD) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-04-24 |
| Decision Date | 1989-07-14 |