FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SCHOLTEN FRAME
K Number: K900405
·
Decision Mar 1, 1990
Classifications
1
FEI Numbers
43
Registration Numbers
43
Same Product Code
12
Applicant Total
8
Review Days
31
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Basic Information
- Device Name
- SCHOLTEN FRAME
- K Number
- K900405
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4950
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Scholten Surgical Instruments, Inc.
- Date Received
- January 29, 1990
- Decision Date
- March 1, 1990
- Product Code
- JEB
- 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 |
|---|---|---|---|
| JEB | Table, Surgical With Orthopedic Accessories, Manual | FDA class 1 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JEB), ordered by most recent decision date.
ORTHOVISION TABLE
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EXTENSION TABLE 1417
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Other Clearances by Scholten Surgical Instruments, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K072051 | NOVATOME, MODEL: SU101-50 | Oct 3, 2007 | Substantially Equivalent |
| K852331 | SYS, ANGIOGRAPHIC, SINGLE-OR BI-PLANE RADIOGRAPHIC | Aug 1, 1986 | Substantially Equivalent |
| K852119 | TEMPORARY PACEMAKER GROUND WIRE | Sep 15, 1985 | Substantially Equivalent |
| K852332 | TABLE ACCESSORIES, OPERATING ROOM | Jul 2, 1985 | Substantially Equivalent |
| K852120 | FORCEPS, BIOPSY(NON RIGID) | Jul 2, 1985 | Substantially Equivalent |
| K852330 | RETRACTOR, SURGICAL | Jun 27, 1985 | Substantially Equivalent |
| K852329 | STAND, OPERATING ROOM | Jun 14, 1985 | Substantially Equivalent |