FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SURGICAL BUR
K Number: K950449
·
Decision Mar 1, 1995
Classifications
1
FEI Numbers
178
Registration Numbers
178
Same Product Code
15
Applicant Total
21
Review Days
26
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Basic Information
- Device Name
- SURGICAL BUR
- K Number
- K950449
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4820
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Transidyne General Corp.
- Date Received
- February 3, 1995
- Decision Date
- March 1, 1995
- Product Code
- GFF
- 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 |
|---|---|---|---|
| GFF | Bur, Surgical, General & Plastic Surgery | FDA class 1 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GFF), ordered by most recent decision date.
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Other Clearances by Transidyne General Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K961217 | BODILY FLUID DISPOSAL KIT | Jul 25, 1996 | Substantially Equivalent |
| K955658 | LACERATION TRAY | Jan 25, 1996 | Substantially Equivalent |
| K950773 | PROPHYLAXIS PACK | Mar 31, 1995 | Unknown |
| K950743 | ORAL PROCEDURE PACK | Mar 31, 1995 | Unknown |
| K950403 | SURGICAL SAW BLADES | Feb 21, 1995 | Substantially Equivalent |
| K924811 | I.V. START KIT | Jun 17, 1993 | Unknown |
| K924243 | TRACHEOSTOMY CARE KIT | Jun 16, 1993 | Unknown |
| K922339 | SUTURE REMOVAL KIT | Dec 11, 1992 | Unknown |
| K922041 | PRIMARY SURGICAL DRESSING TRAY | Nov 6, 1992 | Unknown |
| K897133 | MODEL 1050 - UMBILICAL CORD BLOOD SAMPLING KIT | Mar 30, 1990 | Substantially Equivalent |