FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MEDCARE WOUND CLOSURE TRAY
K Number: K823853
·
Decision Jan 14, 1983
Classifications
1
FEI Numbers
875
Registration Numbers
875
Same Product Code
75
Applicant Total
20
Review Days
23
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Basic Information
- Device Name
- MEDCARE WOUND CLOSURE TRAY
- K Number
- K823853
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4800
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Medcare Products
- Date Received
- December 22, 1982
- Decision Date
- January 14, 1983
- Product Code
- FSM
- 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 |
|---|---|---|---|
| FSM | Tray, Surgical, Instrument | FDA class 1 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FSM), ordered by most recent decision date.
INSTRUMENT TRAY LINER
FDA 510(k)
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·General, Plastic Surgery
SINGLE USE INSTRUMENT TRAY
FDA 510(k)
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SURGICAL INSTRUMENT TRAY
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
ARTHROSCOPY TRAY
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OPEN HEART TRAY
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
HEART CATH TRAY
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Other Clearances by Medcare Products
| K Number | Device Name | ||
|---|---|---|---|
| K841122 | TRACHEOSTOMY CARE TRAY | Apr 25, 1984 | Substantially Equivalent |
| K841124 | DIALYSIS TRAY | Apr 20, 1984 | Substantially Equivalent |
| K841123 | DRESSING CHANGE TRAY | Apr 17, 1984 | Substantially Equivalent |
| K831374 | MED CARE PREP RAZOR | Oct 4, 1983 | Substantially Equivalent |
| K831663 | TISSUE FORCEPS | Sep 26, 1983 | Substantially Equivalent |
| K831664 | PLASTIC THUMB FORCEPS | Sep 12, 1983 | Substantially Equivalent |
| K831665 | DISPOSABLE NEEDLE HOLDER | Sep 12, 1983 | Substantially Equivalent |
| K831661 | DISPOSABLE SCISSORS | Aug 25, 1983 | Substantially Equivalent |
| K831662 | DISPOSABLE HEMOSTAT (STRAIGHT&CURVED | Jul 19, 1983 | Substantially Equivalent |
| K823854 | MEDCARE SUTURE REMOVAL TRAYS | Mar 31, 1983 | Substantially Equivalent |