510(k) K823921
- Device
- PHYSICIANS CHOICE SILICONE EAR PUTTY
- Applicant
- SANTA BARBARA MEDCO, INC.
- 510(k) number
- K823921
- Product code
- LDG
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1983-03-28
- Date received
- 1982-12-28
- Regulation
- 874.3300
- Classification name
- Kit, Earmold, Impression
- Medical specialty
- Ear Nose & Throat
- Review panel
- Ear Nose & Throat
- 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#
- 3010487482
- 3014888923
- 3026045966
- 2523532
- 3004003391
- 3003610251
- 2094377
- 3010863048
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code LDG #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K792428 | COE-SIL | Coe Laboratories, Inc. | 1980-01-23 |
Legacy Summary#
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FDA Review#
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