FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MICRO RASPS
K Number: K780771
·
Decision May 16, 1978
Classifications
1
FEI Numbers
268
Registration Numbers
268
Same Product Code
8
Applicant Total
19
Review Days
11
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Basic Information
- Device Name
- MICRO RASPS
- K Number
- K780771
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4800
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Amsco Co.
- Date Received
- May 5, 1978
- Decision Date
- May 16, 1978
- Product Code
- HTR
- 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 |
|---|---|---|---|
| HTR | Rasp | FDA class 1 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HTR), ordered by most recent decision date.
BIODYNAMICS SMALL JOINT BRUSH #1203
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ACETABULAR BRUSH #1202 & FEMORAL CON. BRUSH #1202
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BIODYNAMICS FEMORAL CANAL BRUSH #1201
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RICHARDS ACETABULAR BRUSH
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THE ARTHROFILE
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INTERMEDULLARY BRUSH
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Other Clearances by Amsco Co.
| K Number | Device Name | ||
|---|---|---|---|
| K912471 | EAGLE 3000 SDS | Jun 26, 1992 | Substantially Equivalent |
| K854922 | AMSCO POLARIS SL | Jan 24, 1986 | Substantially Equivalent |
| K833187 | HALL OSTEON | Oct 31, 1983 | Substantially Equivalent |
| K832945 | EAGLE 2000 STERILIZER SERIES GAS/AERA | Oct 19, 1983 | Substantially Equivalent |
| K832188 | HALL RECIPROCATOR | Aug 12, 1983 | Substantially Equivalent |
| K832187 | HALL OSCILLATOR | Aug 12, 1983 | Substantially Equivalent |
| K831086 | CEILING MOUNTED SUPPORT | Aug 12, 1983 | Substantially Equivalent |
| K832186 | HALL DRILL/REAMER | Aug 12, 1983 | Substantially Equivalent |
| K831309 | DELIVERY 4 TABLE | Jun 15, 1983 | Substantially Equivalent |
| K823360 | SURGICAL LIGHT | Dec 3, 1982 | Substantially Equivalent |