FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
FLORET FOAM PREP SPONGE
K Number: K833626
·
Decision Feb 17, 1984
Classifications
1
FEI Numbers
211
Registration Numbers
211
Same Product Code
110
Applicant Total
22
Review Days
126
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Basic Information
- Device Name
- FLORET FOAM PREP SPONGE
- K Number
- K833626
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4450
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Ritmed, Inc.
- Date Received
- October 14, 1983
- Decision Date
- February 17, 1984
- Product Code
- GDY
- Advisory Committee
- General, Plastic Surgery
- 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 |
|---|---|---|---|
| GDY | Gauze/Sponge, Internal, X-Ray Detectable | FDA class 1 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GDY), ordered by most recent decision date.
ULTRACELL SUCTION SPONGE
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CPR LAP SPONGES
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STRYKER FEMORAL CANAL SPONGE & ACETABULUM SPONGE
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PROTEC X-RAY DETECTABLE GAUZE SPONGE
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FDA Class 1
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KENSORB
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
TRIANGULAR SPONGES
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Other Clearances by Ritmed, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| 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 |
| K830269 | FLORET NEURO SPONGE | Jun 2, 1983 | Substantially Equivalent |