FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
REACH ANTIBACTERIAL TOOTHBRUSH
K Number: K971589
·
Decision Jul 24, 1997
Classifications
1
FEI Numbers
573
Registration Numbers
574
Same Product Code
48
Applicant Total
45
Review Days
84
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Basic Information
- Device Name
- REACH ANTIBACTERIAL TOOTHBRUSH
- K Number
- K971589
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.6855
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Personal Products Co.
- Date Received
- May 1, 1997
- Decision Date
- July 24, 1997
- Product Code
- EFW
- Advisory Committee
- Dental
- Review Advisory Committee
- DE
- 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 |
|---|---|---|---|
| EFW | Toothbrush, Manual | FDA class 1 | Dental |
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Other Clearances by Personal Products Co.
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|---|---|---|---|
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| K010365 | ORTHO CONTROL FEMALE URINARY CONTROL DEVICE | Apr 30, 2001 | Substantially Equivalent |
| K990536 | O.B. TAMPON | Aug 31, 1999 | Substantially Equivalent |
| K991118 | O.B. APPLICATOR TAMPONS, O.B. TAMPONS | Jun 29, 1999 | Substantially Equivalent |
| K974629 | O.B. APPLICATOR AND NON-APPLICATOR TAMPONS | Feb 10, 1998 | Substantially Equivalent |
| K970954 | O.B. APPLICATOR TAMPONS | Jun 10, 1997 | Substantially Equivalent |
| K961119 | CAREFREE PANTYLINERS | Apr 17, 1996 | Substantially Equivalent |
| K953638 | O.B. APPLICATOR TAMPONS | Oct 20, 1995 | Substantially Equivalent |
| K941863 | O.B. TAMPON | Jun 27, 1994 | Substantially Equivalent |