FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
FLORET NASAL TAMPON
K Number: K830263
·
Decision Mar 24, 1983
Classifications
1
FEI Numbers
106
Registration Numbers
106
Same Product Code
45
Applicant Total
22
Review Days
58
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Basic Information
- Device Name
- FLORET NASAL TAMPON
- K Number
- K830263
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 874.4780
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Applicant
- Ritmed, Inc.
- Date Received
- January 25, 1983
- Decision Date
- March 24, 1983
- Product Code
- LYA
- Advisory Committee
- Ear, Nose, Throat
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| LYA | Splint, Intranasal Septal | FDA class 1 | Ear, Nose, Throat |
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Other Clearances by Ritmed, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K833626 | FLORET FOAM PREP SPONGE | Feb 17, 1984 | Substantially Equivalent |
| K832874 | ISOVIS WOUND PROTECTOR | Sep 26, 1983 | Substantially Equivalent |
| K830270 | ISOVIS WOUND PROTECTOR | Jun 24, 1983 | Substantially Equivalent |
| K830267 | FLORET SPECIAL GAUZE SPONGES | Jun 8, 1983 | Substantially Equivalent |
| K830261 | FLORET STRUNG GAUZE SPONGES | Jun 8, 1983 | Substantially Equivalent |
| K830266 | FLORET KITTNER OR K DISSECTOR | Jun 8, 1983 | Substantially Equivalent |
| K830268 | FLORET CYLINDRICAL/BRONCHOSCOPIC/LAMIN | Jun 8, 1983 | Substantially Equivalent |
| K830272 | PROTET HOLDERS-BLOCKS & ROLL | Jun 3, 1983 | Substantially Equivalent |
| K830264 | FLORET TONSIL & ADENOID SPONGES | Jun 3, 1983 | Substantially Equivalent |
| K830271 | LAPET & LAPWALL LAPAROTOMY SPONGES | Jun 2, 1983 | Substantially Equivalent |