FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
SICAT OPTISLEEP
K Number: K153291
·
Decision Mar 31, 2016
Classifications
1
FEI Numbers
105
Registration Numbers
105
Same Product Code
212
Applicant Total
9
Review Days
139
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Basic Information
- Device Name
- SICAT OPTISLEEP
- K Number
- K153291
- Device Class
- FDA class 2
- Clearance Type
- Abbreviated
- Regulation Number
- 872.5570
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Sicat GmbH & Co. KG
- Date Received
- November 13, 2015
- Decision Date
- March 31, 2016
- Product Code
- LRK
- 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 |
|---|---|---|---|
| LRK | Device, Anti-Snoring | FDA class 2 | Dental |
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Myosa (S1H, S1, S2, S3, S1M, S2M); Myosa for Snorers (S1, S1M, S2)
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Other Clearances by Sicat GmbH & Co. KG
| K Number | Device Name | ||
|---|---|---|---|
| K192348 | SICAT Implant V2.0 | Dec 4, 2019 | Substantially Equivalent |
| K180262 | SICAT Endo | Mar 12, 2018 | Substantially Equivalent |
| K143655 | SICAT OPTIMOTION | Oct 2, 2015 | Substantially Equivalent |
| K133320 | SICAT FUNCTION | Feb 25, 2014 | Substantially Equivalent |
| K103723 | SICAT IMPLANT V1.2 | May 20, 2011 | Substantially Equivalent |
| K093090 | GALILEOS IMPLANT, VERSION 1.7 | Dec 17, 2009 | Substantially Equivalent |
| K090119 | SICAT IMPLANT | Feb 5, 2009 | Substantially Equivalent |
| K061472 | GALILEOS IMPLANT, V 1.0 | Jun 9, 2006 | Substantially Equivalent |