FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CENTRAL LINE DRESSING CHANGE TRAY, TPN/CVP DRESSING CHANGE TRAY
K Number: K963719
·
Decision Nov 27, 1996
Classifications
1
FEI Numbers
45
Registration Numbers
45
Same Product Code
23
Applicant Total
8
Review Days
72
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Basic Information
- Device Name
- CENTRAL LINE DRESSING CHANGE TRAY, TPN/CVP DRESSING CHANGE TRAY
- K Number
- K963719
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5075
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Grand Medical Products
- Date Received
- September 16, 1996
- Decision Date
- November 27, 1996
- Product Code
- MCY
- Advisory Committee
- General Hospital
- 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 |
|---|---|---|---|
| MCY | Wound Dressing Kit | FDA class 2 | General Hospital |
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Other Clearances by Grand Medical Products
| K Number | Device Name | ||
|---|---|---|---|
| K963724 | GAUZE SPONGE, NON X-RAY DETECTABLE | Nov 29, 1996 | Substantially Equivalent for Some Indications |
| K963715 | DEBRIDEMENT TRAY, INCISION AND DRAINAGE TRAY | Nov 27, 1996 | Substantially Equivalent |
| K963720 | TRACHEOSTOMY KIT | Nov 27, 1996 | Substantially Equivalent |
| K963723 | LACERATION TRAY | Nov 27, 1996 | Substantially Equivalent |
| K963714 | GRAND MEDICAL SUTURE REMOVAL KIT | Nov 27, 1996 | Substantially Equivalent |
| K963721 | SKIN SCRUB TRAY | Nov 27, 1996 | Substantially Equivalent |
| K963722 | IV START KIT | Nov 27, 1996 | Substantially Equivalent |