FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
REPROCESSES USED DISPOSABLE SEQUENTIAL COMPRESSION SLEEVES/WRAPS
K Number: K022753
·
Decision Nov 14, 2002
Classifications
1
FEI Numbers
129
Registration Numbers
129
Same Product Code
349
Applicant Total
5
Review Days
87
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Basic Information
- Device Name
- REPROCESSES USED DISPOSABLE SEQUENTIAL COMPRESSION SLEEVES/WRAPS
- K Number
- K022753
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.5800
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Medical Device Services
- Date Received
- August 19, 2002
- Decision Date
- November 14, 2002
- Product Code
- JOW
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- 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 |
|---|---|---|---|
| JOW | Sleeve, Limb, Compressible | FDA class 2 | Cardiovascular |
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Other Clearances by Medical Device Services
| K Number | Device Name | ||
|---|---|---|---|
| K022751 | REPROCESSED USED DISPOSABLE HOT AND COLD BIOPSY FORCEPS | Nov 4, 2002 | Substantially Equivalent |
| K022743 | REPROCESSED DISPOSABLE TROCARS | Oct 9, 2002 | Substantially Equivalent |
| K022748 | REPROCSSED USED DISPOSABLE ENDOSCOPIC SCISSORS AND GRASPERS | Oct 9, 2002 | Substantially Equivalent |
| K022744 | REPROCESSED USED DISPOSABLE ARTHROSCOPIC BLADES AND BURS | Sep 18, 2002 | Substantially Equivalent |