FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
#556 DISPOSABLE UMBILICAL CORD CLAMP (2)
K Number: K894646
·
Decision Sep 5, 1989
Classifications
1
FEI Numbers
52
Registration Numbers
52
Same Product Code
35
Applicant Total
10
Review Days
43
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Basic Information
- Device Name
- #556 DISPOSABLE UMBILICAL CORD CLAMP (2)
- K Number
- K894646
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.4530
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Applicant
- Alpha Unlimited, Inc.
- Date Received
- July 24, 1989
- Decision Date
- September 5, 1989
- Product Code
- HFW
- Advisory Committee
- Obstetrics/Gynecology
- Review Advisory Committee
- OB
- 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 |
|---|---|---|---|
| HFW | Clamp, Umbilical | FDA class 2 | Obstetrics/Gynecology |
Similar 510(k) Clearances
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Other Clearances by Alpha Unlimited, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K893428 | ALPHA SHOPPER | Jun 12, 1989 | Substantially Equivalent |
| K893429 | ALPHA CONDOR | Jun 12, 1989 | Substantially Equivalent |
| K893248 | ALPHA MALLARD | May 26, 1989 | Substantially Equivalent |
| K853766 | ALPHA SUPER KART | Nov 20, 1985 | Substantially Equivalent |
| K841921 | ALPHA PLUS 1 | May 23, 1984 | Substantially Equivalent |
| K841911 | ALPHA PUSH KART | May 23, 1984 | Substantially Equivalent |
| K841919 | ALPHA TRI-KART | May 23, 1984 | Substantially Equivalent |
| K841912 | ALPHA 4 X 4 | May 23, 1984 | Substantially Equivalent |
| K841920 | MAC-MULTI-ADJUSTABLE CHAIR | May 23, 1984 | Substantially Equivalent |