FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
RABINOWITZ GUM MASSAGER
K Number: K862635
·
Decision Sep 25, 1986
Classifications
1
FEI Numbers
47
Registration Numbers
48
Same Product Code
2
Applicant Total
1
Review Days
77
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Basic Information
- Device Name
- RABINOWITZ GUM MASSAGER
- K Number
- K862635
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.6650
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Arnell, Inc.
- Date Received
- July 10, 1986
- Decision Date
- September 25, 1986
- Product Code
- JEW
- 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 |
|---|---|---|---|
| JEW | Tip, Rubber, Oral Hygiene | FDA class 1 | Dental |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JEW), ordered by most recent decision date.
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