FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
RASPS
K Number: K822253
·
Decision Aug 25, 1982
Classifications
1
FEI Numbers
43
Registration Numbers
43
Same Product Code
0
Applicant Total
94
Review Days
27
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Basic Information
- Device Name
- RASPS
- K Number
- K822253
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 874.4420
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Applicant
- Kelleher Corp.
- Date Received
- July 29, 1982
- Decision Date
- August 25, 1982
- Product Code
- JYY
- Advisory Committee
- Ear, Nose, Throat
- Review Advisory Committee
- EN
- 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 |
|---|---|---|---|
| JYY | Rasp, Ear | FDA class 1 | Ear, Nose, Throat |
Other Clearances by Kelleher Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K822268 | NAGASHIMA NS-III ELECTRONYSTAGMOGRAPH | Jan 28, 1983 | Substantially Equivalent |
| K822618 | EMERGENCY TRACHEOSTOMY INSTRUMENT SET | Jan 28, 1983 | Substantially Equivalent |
| K823083 | ELECTROSURGICAL UNIT | Dec 7, 1982 | Substantially Equivalent |
| K823111 | NYSTYMOGRAPH ACCESS | Nov 22, 1982 | Substantially Equivalent |
| K822252 | ENT TREATMENT UNITS | Nov 22, 1982 | Substantially Equivalent |
| K822272 | HEAD MIRRORS W/HEAD LAMPS & HEAD BANDS | Nov 10, 1982 | Substantially Equivalent |
| K822017 | TYMPANOSTOMY TUBES & VARIOUS TYPES | Oct 27, 1982 | Substantially Equivalent |
| K822257 | VARIOUS TYPES OF LIGHT SOURCE HANDLES | Oct 26, 1982 | Substantially Equivalent |
| K822259 | LARYNGEAL SPATULAS | Oct 22, 1982 | Substantially Equivalent |
| K822004 | FACE SHIELDS | Oct 20, 1982 | Substantially Equivalent |