FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
WELCON LIGHT HANDLE
K Number: K894397
·
Decision Aug 10, 1989
Classifications
1
FEI Numbers
93
Registration Numbers
93
Same Product Code
25
Applicant Total
8
Review Days
21
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Basic Information
- Device Name
- WELCON LIGHT HANDLE
- K Number
- K894397
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4580
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Welcon, Inc.
- Date Received
- July 20, 1989
- Decision Date
- August 10, 1989
- Product Code
- FTA
- 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 |
|---|---|---|---|
| FTA | Light, Surgical, Accessories | FDA class 2 | General, Plastic Surgery |
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Other Clearances by Welcon, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K003402 | WELCON STERILE WATER FOR DEVICE IRRIGATION; WELCON STERILE 0.9% NORMAL SALINE FOR DEVICE IRRIGATION | May 1, 2001 | Substantially Equivalent |
| K973734 | STERILE WATER FOR DEVICE IRRIGATION/ STERILE SALINE FOR DEVICE IRRIGATION | Feb 5, 1998 | Substantially Equivalent |
| K971764 | WELCON HUE-VU URINARY DRAINAGE BAG | Jul 29, 1997 | Substantially Equivalent |
| K912869 | WOMEN AND INFANT'S DELIVERY PACK | Dec 4, 1991 | Substantially Equivalent |
| K904158 | ACCORDE(R) IRRIGATING SYRINGE/PROCEDURE TRAY | Nov 29, 1990 | Unknown |
| K830359 | STERILE CATHERIZATION PROCEDURE TRAYS | Mar 17, 1983 | Substantially Equivalent |
| K813027 | STERILE IRRIGATING SYRINGES, KITS,TRAY | Nov 20, 1981 | Substantially Equivalent |