FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
JACKSON-PRATT HEMADUCT WOUND DRAIN, JACKSON-PRATT GOLD HEMADUCT WOUND DRAIN
K Number: K973703
·
Decision Dec 4, 1997
Classifications
1
FEI Numbers
243
Registration Numbers
243
Same Product Code
76
Applicant Total
63
Review Days
69
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Basic Information
- Device Name
- JACKSON-PRATT HEMADUCT WOUND DRAIN, JACKSON-PRATT GOLD HEMADUCT WOUND DRAIN
- K Number
- K973703
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4200
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Allegiance Healthcare Corp.
- Date Received
- September 26, 1997
- Decision Date
- December 4, 1997
- Product Code
- GBX
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| GBX | Catheter, Irrigation | FDA class 1 | General, Plastic Surgery |
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Other Clearances by Allegiance Healthcare Corp.
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|---|---|---|---|
| K023673 | AIRLIFE DEMAND NASAL CANNULA | May 2, 2003 | Substantially Equivalent |
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| K024292 | MODIFICATION TO POSITIVE TOUCH POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN AND CHEMOTHERAPY LABELING CLAIM | Jan 9, 2003 | Substantially Equivalent |
| K024102 | DENTAL POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM | Dec 18, 2002 | Substantially Equivalent |
| K023425 | DRAPES WITH ABSORBENT REINFORCEMENT | Nov 6, 2002 | Substantially Equivalent |
| K022765 | NITRILE POWDER-FREE EXAMINATION GLOVES | Oct 11, 2002 | Substantially Equivalent |
| K023170 | NITRILE POWDER-FREE EXAMINATION GLOVES | Oct 9, 2002 | Substantially Equivalent |
| K023167 | BREATHABLE SURGICAL GOWN | Oct 2, 2002 | Substantially Equivalent |
| K012931 | GENESIS STERRAD COMPATIBLE REUSABLE STERILIZATION CONTAINER SYSTEM | Aug 20, 2002 | Substantially Equivalent |