FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PORTASPIR II
K Number: K851560
·
Decision Dec 13, 1985
Classifications
1
FEI Numbers
98
Registration Numbers
98
Same Product Code
158
Applicant Total
24
Review Days
241
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Basic Information
- Device Name
- PORTASPIR II
- K Number
- K851560
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4780
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Roseburg SA
- Date Received
- April 16, 1985
- Decision Date
- December 13, 1985
- Product Code
- BTA
- 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 |
|---|---|---|---|
| BTA | Pump, Portable, Aspiration (Manual Or Powered) | FDA class 2 | General, Plastic Surgery |
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Other Clearances by Roseburg SA
| K Number | Device Name | ||
|---|---|---|---|
| K931155 | STAPLE, FIXATION BONE; SCREW FIXATION BONE | Sep 1, 1994 | Substantially Equivalent |
| K890081 | CALIUS-ISABEL CANOVAS SUNGLASSES | Mar 9, 1989 | Substantially Equivalent |
| K885275 | ASSENAT-BLESCHET SUNGLASSES | Jan 24, 1989 | Substantially Equivalent |
| K882392 | BURNET LABORATOIRE PHARMACEUTIQUE SURGICAL GLOVES | Aug 26, 1988 | Substantially Equivalent |
| K872715 | UNIVERSAL INSTRUMENTATION(CD) FOR SPINAL SURGERY | Dec 7, 1987 | Substantially Equivalent for Some Indications |
| K874317 | POIRIER KID-ROLLER MANUAL WHEELCHAIR | Nov 17, 1987 | Substantially Equivalent |
| K872714 | S.T.A.C.E.M. EXTERNAL BREAST PROSTHESIS MAMMARY | Jul 21, 1987 | Substantially Equivalent |
| K871688 | SPECTACLE FRAME - DANIELLE | May 29, 1987 | Substantially Equivalent |
| K871689 | SPECTACLE FRAME - LORRAINE | May 29, 1987 | Substantially Equivalent |
| K870654 | EFER ARTHROSCOPE | May 14, 1987 | Substantially Equivalent |