510(k) K830259
- Device
- PROTET SOAP & WASH MITT
- Applicant
- RITMED, INC.
- 510(k) number
- K830259
- Product code
- GED
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1983-05-09
- Date received
- 1983-01-25
- Regulation
- 878.4800
- Classification name
- Brush, Dermabrasion, Manual
- Medical specialty
- General & Plastic Surgery
- Review panel
- General & Plastic Surgery
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 3018034305
- 3015139841
- 3013360665
- 3011089435
- 3010332886
- 3010057495
- 9612390
- 3011850237
- 3026326493
- 3016020790
- 3030726486
- 3010339057
- 3027725665
- 3016420624
- 3020285
- 3031594237
- 3012251300
- 3021334828
- 3007597038
- 3004950768
- 1720929
- 3027320022
- 3006128100
- 3030186176
- 2020550
- 3015168527
- 3045063937
- 2029275
- 3024787345
- 3013178978
- 3024682182
- 3010202439
- 2027062
- 3037407231
- 3003807268
- 3008346537
- 1820334
- 3014388884
- 3008650974
- 3017555752
- 3025034781
- 3012833978
- 3003015433
- 1836161
- 3010360273
- 3011862887
- 3005630901
- 3013463240
- 3010097171
- 1825146
- 3021386681
- 2028632
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code GED #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K821801 | NORSEN DEBRIDER | Bel-Med, Inc. | 1982-07-28 |
Legacy Summary#
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FDA Review#
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