FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
GRAND MEDICAL SUTURE REMOVAL KIT
K Number: K963714
·
Decision Nov 27, 1996
Classifications
1
FEI Numbers
56
Registration Numbers
56
Same Product Code
14
Applicant Total
8
Review Days
72
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Basic Information
- Device Name
- GRAND MEDICAL SUTURE REMOVAL KIT
- K Number
- K963714
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4800
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Grand Medical Products
- Date Received
- September 16, 1996
- Decision Date
- November 27, 1996
- Product Code
- MCZ
- 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 |
|---|---|---|---|
| MCZ | Suture Removal Kit | FDA class 1 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (MCZ), ordered by most recent decision date.
AMSINO SUTURE REMOVAL KIT
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PROD. NO. 01-132 - SUTURE REMOVAL KIT
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SKIN STAPLE REMOVAL TRAYS
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SUTURE REMOVAL KIT
FDA 510(k)
FDA Class 1
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CARAPACE INCISION AND DRAINAGE TRAYS
FDA 510(k)
FDA Class 1
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STERILE SUTURE REMOVAL KIT
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
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 |
| K963719 | CENTRAL LINE DRESSING CHANGE TRAY, TPN/CVP DRESSING CHANGE TRAY | Nov 27, 1996 | Substantially Equivalent |
| K963723 | LACERATION TRAY | Nov 27, 1996 | Substantially Equivalent |
| K963721 | SKIN SCRUB TRAY | Nov 27, 1996 | Substantially Equivalent |
| K963722 | IV START KIT | Nov 27, 1996 | Substantially Equivalent |