FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SUTURE REMOVAL SET(DISPLSABLE)
K Number: K811086
·
Decision May 1, 1981
Classifications
1
FEI Numbers
329
Registration Numbers
330
Same Product Code
61
Applicant Total
10
Review Days
10
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Basic Information
- Device Name
- SUTURE REMOVAL SET(DISPLSABLE)
- K Number
- K811086
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4800
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Cunningham Woodland, Inc.
- Date Received
- April 21, 1981
- Decision Date
- May 1, 1981
- Product Code
- KDD
- 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 |
|---|---|---|---|
| KDD | Kit, Surgical Instrument, Disposable | FDA class 1 | General, Plastic Surgery |
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Other Clearances by Cunningham Woodland, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K823527 | SUBCLAVIAN INSERTION KIT | Mar 31, 1983 | Substantially Equivalent |
| K813286 | PRE-PACK TENS | Jan 22, 1982 | Substantially Equivalent |
| K813519 | NON-ABSORBENT TOWELS | Jan 5, 1982 | Substantially Equivalent |
| K813284 | VENOUS CANNULA TRAY | Dec 29, 1981 | Substantially Equivalent |
| K811090 | MAJOR DRESSING TRAY | May 8, 1981 | Substantially Equivalent |
| K811091 | MINOR DRESSING TRAY | May 8, 1981 | Substantially Equivalent |
| K811089 | ONE STEP PREP KIT | May 8, 1981 | Substantially Equivalent |
| K811088 | DRESSING TRAY MERCY HOSPITAL | May 8, 1981 | Substantially Equivalent |
| K811087 | MIKA SKIN SCRUB TRAY PRE OPERATIVE W/GEL | May 1, 1981 | Substantially Equivalent |