FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
HOLE CHAMFERING DEVICE
K Number: K841298
·
Decision Apr 25, 1984
Classifications
1
FEI Numbers
178
Registration Numbers
178
Same Product Code
15
Applicant Total
31
Review Days
26
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Basic Information
- Device Name
- HOLE CHAMFERING DEVICE
- K Number
- K841298
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4820
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Techmedica, Inc.
- Date Received
- March 30, 1984
- Decision Date
- April 25, 1984
- 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.
ANSPACH SHIELDED ATTACHMENT
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Other Clearances by Techmedica, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K933935 | CKS POROUS COATED FEMORAL COMPONENT | Oct 11, 1994 | Substantially Equivalent |
| K932017 | TECHMEDICA CONTINUUM HIP WITH HA COATING | Sep 1, 1994 | Substantially Equivalent |
| K931929 | TECHMEDICA CONTINUUM HIP SYSTEM | Mar 29, 1994 | Substantially Equivalent |
| K926387 | TECHMEDICA STANDARD CEMENTED HIP SYSTEM | Feb 1, 1994 | Substantially Equivalent |
| K925420 | TECHMEDICA STANDARD BIPOLAR SYSTEM | Sep 28, 1993 | Substantially Equivalent |
| K923808 | MULLER STRAIGHT STEM FEMORAL PROSTHESIS | Jul 27, 1993 | Substantially Equivalent |
| K926579 | TECHMEDICA 6.5MM SELF-TAPPING CANCELLOUS BONE SCRE | Apr 6, 1993 | Substantially Equivalent |
| K911058 | TECHMEDICA CAD/CAM CUSTOM HIP | Feb 23, 1993 | Substantially Equivalent |
| K925181 | TECHMEDICA MUELLER TYPE POLYETHYLENE ACETBUL CUP | Feb 5, 1993 | Substantially Equivalent |
| K920080 | CONTINUUM KNEE SYSTEM | Sep 1, 1992 | Substantially Equivalent for Some Indications |