FDA 510(k)
Substantially Equivalent
🇺🇸 United States
CARE + PLUS SUTURE REMOVAL TRAY
K Number: K863283
·
Decision Sep 15, 1986
Classifications
0
FEI Numbers
0
Registration Numbers
0
Same Product Code
0
Applicant Total
7
Review Days
21
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Basic Information
- Device Name
- CARE + PLUS SUTURE REMOVAL TRAY
- K Number
- K863283
- Clearance Type
- Traditional
- Decision
- Substantially Equivalent
- Applicant
- Welmed Systems, Inc.
- Date Received
- August 25, 1986
- Decision Date
- September 15, 1986
- Advisory Committee
- Unknown
- Review Advisory Committee
- SU
- Third Party
- N
Other Clearances by Welmed Systems, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K863282 | CARE + PLUS CATHETER CARE TRAY | Oct 31, 1986 | Substantially Equivalent |
| K863281 | CARE + PLUS IRREGATION TRAY | Oct 31, 1986 | Substantially Equivalent |
| K863497 | SUCTION CATHETER KIT | Oct 6, 1986 | Substantially Equivalent |
| K863284 | I.V. START KIT | Sep 22, 1986 | Unknown |
| K862663 | TRACHEOSTOMY CARE TRAY | Jul 30, 1986 | Substantially Equivalent |
| K862219 | T.P.N. DRESSING CHANGE TRAY | Jul 8, 1986 | Unknown |