FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
THE NEW FLEXIBLE COLLAPSIBLE CHAMBER
K Number: K861101
·
Decision May 6, 1986
Classifications
1
FEI Numbers
17
Registration Numbers
17
Same Product Code
22
Applicant Total
4
Review Days
43
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- THE NEW FLEXIBLE COLLAPSIBLE CHAMBER
- K Number
- K861101
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.5650
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Stephenson Industries, Inc.
- Date Received
- March 24, 1986
- Decision Date
- May 6, 1986
- Product Code
- KPJ
- 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 |
|---|---|---|---|
| KPJ | Chamber, Oxygen, Topical, Extremity | FDA class 2 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KPJ), ordered by most recent decision date.
Wound Treatment System (VHT-200)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
VHT-200 Wound Treatment System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
EPIFLO-28
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
NATROX TOPICAL OXYGEN DELIVERY SYSTEM WITH IODP
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
EPIFLO(R)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
TANSCU O2
FDA 510(k)
FDA Class 2
·General, Plastic Surgery