FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
FIBRELIGHT NASAL SPECULA
K Number: K853588
·
Decision Dec 18, 1985
Classifications
1
FEI Numbers
228
Registration Numbers
228
Same Product Code
11
Applicant Total
60
Review Days
113
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Basic Information
- Device Name
- FIBRELIGHT NASAL SPECULA
- K Number
- K853588
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.1800
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Downs Surgical , Ltd.
- Date Received
- August 27, 1985
- Decision Date
- December 18, 1985
- Product Code
- EPY
- 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 |
|---|---|---|---|
| EPY | Speculum, Ent | FDA class 1 | General, Plastic Surgery |
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Other Clearances by Downs Surgical , Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K903749 | ISLAM STERNAL PUNCTURE NEEDLE, CAT #AG-596-00-U | Oct 31, 1990 | Substantially Equivalent |
| K903748 | ISLAM STERNAL PUNCTURE NEEDLE, CAT # AF-594-00-V | Oct 31, 1990 | Substantially Equivalent |
| K903750 | ISLAM STERNAL PUNCTURE NEEDLE, CAT #AG-598-OO-E | Oct 31, 1990 | Substantially Equivalent |
| K903747 | ISLAM STERNAL PUNCTURE NEEDLE, CAT # AG-592-00-U | Oct 31, 1990 | Substantially Equivalent |
| K900611 | SHEPPERD DILATATION TUBE SET (GS-501-20-H) | Oct 22, 1990 | Substantially Equivalent |
| K900614 | SHEPPERD SHORT MUSCLE RETRACTOR (GS-501-45-V) | Oct 22, 1990 | Substantially Equivalent |
| K900612 | SHEPPERD TREPHINE SET (GS-501-30-V) | Oct 22, 1990 | Substantially Equivalent |
| K900610 | SHEPPERD CANNULA STILLETTE & OBDURATOR SET | Oct 22, 1990 | Substantially Equivalent |
| K900616 | SHEPPERD CUTTING FORCEPS | Oct 22, 1990 | Substantially Equivalent |
| K900609 | SHEPPERD STRAIGHT AND CURVED NEEDLES | Oct 22, 1990 | Substantially Equivalent |