FDA 510(k)
FDA class 2
Unknown
🇺🇸 United States
TOCOLYTIC SITE CARE SUP KIT #1001/100A/CARRY CASE
K Number: K893003
·
Decision Jul 14, 1989
Classifications
1
FEI Numbers
204
Registration Numbers
205
Same Product Code
503
Applicant Total
5
Review Days
81
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Basic Information
- Device Name
- TOCOLYTIC SITE CARE SUP KIT #1001/100A/CARRY CASE
- K Number
- K893003
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5200
- Medical Specialty
- General Hospital
- Decision
- Unknown
- Applicant
- United Medical Systems, Inc.
- Date Received
- April 24, 1989
- Decision Date
- July 14, 1989
- Product Code
- FOZ
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| FOZ | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | FDA class 2 | General Hospital |
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Other Clearances by United Medical Systems, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K072538 | PIEZOLITH 3000 TRIPLE-FOCUS LITHOTRIPTER | Jan 30, 2008 | Substantially Equivalent |
| K032958 | PIEZOLITH 3000 LITHOTRIPTER, MODEL 3000 | Feb 17, 2004 | Substantially Equivalent |
| K894949 | SQA | Dec 29, 1989 | Substantially Equivalent |
| K863645 | SCHULMAN DOUBLE UMBILICAL CORD CLAMP NO. 1000 | Sep 25, 1986 | Substantially Equivalent |