FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
LEBODY BY WATER PIK
K Number: K801593
·
Decision Aug 20, 1980
Classifications
1
FEI Numbers
759
Registration Numbers
759
Same Product Code
99
Applicant Total
10
Review Days
37
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Basic Information
- Device Name
- LEBODY BY WATER PIK
- K Number
- K801593
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 890.5660
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Applicant
- Teledyne, Inc.
- Date Received
- July 14, 1980
- Decision Date
- August 20, 1980
- Product Code
- ISA
- Advisory Committee
- Physical Medicine
- Review Advisory Committee
- PM
- 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 |
|---|---|---|---|
| ISA | Massager, Therapeutic, Electric | FDA class 1 | Physical Medicine |
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Other Clearances by Teledyne, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K871828 | TED MODEL 760 | Feb 4, 1988 | Substantially Equivalent |
| K863131 | PIK POCKET (IRRIGATING TIP) | Aug 26, 1986 | Substantially Equivalent |
| K862695 | FLUOR-ETCH GEL ETCHANT | Jul 31, 1986 | Substantially Equivalent |
| K854817 | INSTAPURE | Feb 28, 1986 | Substantially Equivalent |
| K840721 | PERIO PIK | Apr 25, 1984 | Substantially Equivalent |
| K810864 | WATER PIK ORAL HYGIENE CENTER | Apr 21, 1981 | Substantially Equivalent |
| K810805 | WATER PIK AUTOMATIC TOOTHBRUSH | Apr 14, 1981 | Substantially Equivalent |
| K800919 | ORAVIEW BY WATER PIK | May 8, 1980 | Substantially Equivalent |
| K800448 | WATER PIK TRAVELER, MODEL 79 | Mar 5, 1980 | Substantially Equivalent |