FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
AQUAPLAST TIE DOWN DRESSING
K Number: K943871
·
Decision Sep 30, 1994
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
1
Applicant Total
8
Review Days
53
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Basic Information
- Device Name
- AQUAPLAST TIE DOWN DRESSING
- K Number
- K943871
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4014
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Wfr/Aquaplast Corp.
- Date Received
- August 8, 1994
- Decision Date
- September 30, 1994
- Product Code
- LZM
- 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 |
|---|---|---|---|
| LZM | Guard, Skin Graft | FDA class 1 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LZM), ordered by most recent decision date.
View allOther Clearances by Wfr/Aquaplast Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K120916 | QFIX RADIOTHERAPY CHAIR | Jun 20, 2012 | Substantially Equivalent |
| K060671 | KVUE IGRT TREATMENT TABLE TOP, RT-4551KV, KVUE INSERTS AND ACCESSORIES, VARIOUS | May 4, 2006 | Substantially Equivalent |
| K032156 | ACCUFIX RADIOLUCENT PELVIS AND BELLY BOARDS, ACCUFIX CANTILEVER HEAD BOARD WITH SHOULDER DEPRESSION, ACCUFIX RADIOLUCENT | Sep 2, 2003 | Substantially Equivalent |
| K021124 | ACCUFIX TILTING RADIOTRANSLUCENT HEADHOLDER | Jul 2, 2002 | Substantially Equivalent |
| K973370 | AQUAPLAST PALATAL STENT | Dec 2, 1997 | Substantially Equivalent |
| K942158 | AQUAPLAST NASAL SPLINTS, PRECUT SILVER SPLINT PATTERNS AND SPLINT KITS | Jul 29, 1994 | Substantially Equivalent |
| K935067 | AQUAPLAST | May 26, 1994 | Substantially Equivalent |