FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
TONSIL KNIFE-VARIOUS
K Number: K841005
·
Decision May 30, 1984
Classifications
1
FEI Numbers
50
Registration Numbers
50
Same Product Code
0
Applicant Total
41
Review Days
82
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Basic Information
- Device Name
- TONSIL KNIFE-VARIOUS
- K Number
- K841005
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 874.4420
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Applicant
- Premier Dental Products Co.
- Date Received
- March 9, 1984
- Decision Date
- May 30, 1984
- Product Code
- KBQ
- 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 |
|---|---|---|---|
| KBQ | Knife, Tonsil | FDA class 1 | Ear, Nose, Throat |
Other Clearances by Premier Dental Products Co.
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|---|---|---|---|
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| K062166 | ENAMEL PRO | Nov 21, 2006 | Substantially Equivalent |
| K061997 | PREMIER SELF-ETCHING ENAMEL SEALANT | Oct 4, 2006 | Substantially Equivalent |
| K061998 | PREMIER SELF-ETCHING BOND ENHANCER | Oct 4, 2006 | Substantially Equivalent |
| K051866 | PREMIER TEMPORARY CEMENT | Sep 6, 2005 | Substantially Equivalent |
| K042215 | RADIOPAQUE, GLASS IONOMER ENDODONTIC CEMENT | Sep 21, 2004 | Substantially Equivalent |