FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SNORE GUARD
K Number: K103004
·
Decision Feb 25, 2011
Classifications
1
FEI Numbers
105
Registration Numbers
105
Same Product Code
212
Applicant Total
8
Review Days
140
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Basic Information
- Device Name
- SNORE GUARD
- K Number
- K103004
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 872.5570
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Ranir, LLC
- Date Received
- October 8, 2010
- Decision Date
- February 25, 2011
- 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 Ranir, LLC
| K Number | Device Name | ||
|---|---|---|---|
| K133423 | REST ASSURED EXTRA COMFORT NITE PROTECTOR | Dec 20, 2013 | Substantially Equivalent |
| K120103 | REST ASSURED GENERATION III DENTAL PROTECTOR | Feb 3, 2012 | Substantially Equivalent |
| K112879 | REST ASSURED READY TO WEAR NITE PROTECTOR | Jan 27, 2012 | Substantially Equivalent |
| K102118 | SNORE GUARD ADVANCE | Sep 8, 2010 | Substantially Equivalent |
| K094020 | GRIND NO MORE GENERATION II | Jan 25, 2010 | Substantially Equivalent |
| K091175 | GRIND NO MORE VERSION 2 AND 3 | May 8, 2009 | Substantially Equivalent |
| K063229 | REST ASSURED NITE PROTECTOR | Dec 19, 2006 | Substantially Equivalent |