FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
EQUIPMENT SLUSH DRAPE
K Number: K053495
·
Decision Mar 16, 2006
Classifications
1
FEI Numbers
200
Registration Numbers
200
Same Product Code
449
Applicant Total
32
Review Days
91
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Basic Information
- Device Name
- EQUIPMENT SLUSH DRAPE
- K Number
- K053495
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4370
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Advance Medical Designs, Inc.
- Date Received
- December 15, 2005
- Decision Date
- March 16, 2006
- Product Code
- KKX
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| KKX | Drape, Surgical, Antimicrobial | FDA class 2 | General, Plastic Surgery |
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|---|---|---|---|
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| K011265 | ULTRASOUND TRANSDUCER COVER | Oct 30, 2001 | Substantially Equivalent |
| K012168 | ADVANCE MEDICAL DESIGNS FLUID POUCH | Sep 18, 2001 | Substantially Equivalent |
| K011422 | SURGICAL DRAPES | Jul 10, 2001 | Substantially Equivalent |
| K003670 | PATIENT DRAPE, SURGICAL | Jan 26, 2001 | Substantially Equivalent |
| K911884 | ADVANCE PRESSURE MONITOR/HIGH PRESSURE LINES | Jul 5, 1994 | Substantially Equivalent |
| K925115 | AMD DENTIST AND HYGIENIST KITS | Jul 5, 1994 | Substantially Equivalent |
| K915301 | ADVANCE STOPCOCK/HIGH PRESSURE STOPCOCK | Dec 11, 1992 | Substantially Equivalent |
| K911732 | ADVANCE DISPOSABLE CONTROL SYRINGE | Sep 16, 1991 | Substantially Equivalent |