RABINOWITZ GUM MASSAGER
FDA 510(k) clearance K862635 · decided 1986-09-25
Clearance details
- K-number
- K862635
- Device name
- RABINOWITZ GUM MASSAGER
- Applicant
- Arnell, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1986-07-10
- Decision date
- 1986-09-25
- Days to decision
- 77 days
- Clearance type
- Traditional
- Product code
- JEW
- Device class
- 1
- Regulation number
- 872.6650
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Glendale, AZ, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| CHEW-DENT (K843406) | Senair-Mot | 1984-12-11 |
| ASSAY REAGENTS, LSA 290 (K790588) | Kallestad Laboratories, Inc. | 1979-05-15 |
Recalls involving this device
No recalls on record reference this clearance.