FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
FEATHERLIFT EXTENDED APTOS THREAD
K Number: K043591
·
Decision Mar 4, 2005
Classifications
1
FEI Numbers
108
Registration Numbers
108
Same Product Code
84
Applicant Total
6
Review Days
66
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Basic Information
- Device Name
- FEATHERLIFT EXTENDED APTOS THREAD
- K Number
- K043591
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.5010
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Kmi Kolster Methods, Inc.
- Date Received
- December 28, 2004
- Decision Date
- March 4, 2005
- Product Code
- GAW
- 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 |
|---|---|---|---|
| GAW | Suture, Nonabsorbable, Synthetic, Polypropylene | FDA class 2 | General, Plastic Surgery |
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Other Clearances by Kmi Kolster Methods, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K060414 | KOLSTER METHODS, INC., FEATHERLIFT SILHOUETTE SUTURE | Oct 23, 2006 | Substantially Equivalent |
| K012236 | STARS2000 POWER CANNULA | Nov 19, 2001 | Substantially Equivalent |
| K010702 | XUB EXTERNAL ULTRASOUND | Aug 9, 2001 | Substantially Equivalent |
| K002859 | SSW-STERILE SOLUTION WARMER | Nov 16, 2000 | Substantially Equivalent |
| K991203 | IRRIGATION OR INFUSION PUMP K PUMP | Oct 15, 1999 | Substantially Equivalent |