FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
PROBES, VARIOUS
K Number: K841003
·
Decision Mar 20, 1984
Classifications
1
FEI Numbers
113
Registration Numbers
113
Same Product Code
43
Applicant Total
41
Review Days
11
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Basic Information
- Device Name
- PROBES, VARIOUS
- K Number
- K841003
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 876.4730
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Premier Dental Products Co.
- Date Received
- March 9, 1984
- Decision Date
- March 20, 1984
- Product Code
- KOA
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- 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 |
|---|---|---|---|
| KOA | Surgical Instruments, G-U, Manual (And Accessories) | FDA class 1 | Gastroenterology, Urology |
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| 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 |