FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
LUCAE'S EAR & NASAL APPLICATORS
K Number: K832667
·
Decision Sep 29, 1983
Classifications
1
FEI Numbers
134
Registration Numbers
134
Same Product Code
3
Applicant Total
12
Review Days
51
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Basic Information
- Device Name
- LUCAE'S EAR & NASAL APPLICATORS
- K Number
- K832667
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 874.5220
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Applicant
- Kells Medical, Inc.
- Date Received
- August 9, 1983
- Decision Date
- September 29, 1983
- Product Code
- KCJ
- Advisory Committee
- Ear, Nose, Throat
- Review Advisory Committee
- EN
- 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 |
|---|---|---|---|
| KCJ | Applicator, Ent | FDA class 1 | Ear, Nose, Throat |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KCJ), ordered by most recent decision date.
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APDYNE PHENOL APPLICATOR KIT
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Other Clearances by Kells Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K926333 | CPR PLUS | Nov 8, 1993 | Substantially Equivalent |
| K890093 | PVC EMPTY SOLUTION CONTAINER ENTERAL PUMP SET | Jul 24, 1989 | Substantially Equivalent |
| K890095 | PVC EMPTY SOLUTION CONTAINER W/3 LEAD TRANSFER SET | May 24, 1989 | Substantially Equivalent |
| K890094 | EVA EMPTY SOLUTION CONTAINER W/3 LEAD TRANSFER SET | May 24, 1989 | Substantially Equivalent |
| K861972 | DERMISTRIP | Jun 27, 1986 | Substantially Equivalent for Some Indications |
| K844463 | DERMIDRESS | Jan 8, 1985 | Substantially Equivalent |
| K844072 | DERMIZIP SKIN CLOSURE DEVICE | Nov 5, 1984 | Substantially Equivalent |
| K832678 | PHONATORY FUNCTION ANALYZER PS-77 | Mar 7, 1984 | Substantially Equivalent |
| K823118 | SAY | Jan 7, 1983 | Substantially Equivalent |
| K823226 | SN-100 DOCTOR'S ROUND | Nov 22, 1982 | Substantially Equivalent |