FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
CAT. 7-EAR, NOSE & THROAT DEVICES
K Number: K840311
·
Decision May 9, 1984
Classifications
1
FEI Numbers
140
Registration Numbers
140
Same Product Code
3
Applicant Total
52
Review Days
106
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Basic Information
- Device Name
- CAT. 7-EAR, NOSE & THROAT DEVICES
- K Number
- K840311
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 874.5220
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Applicant
- Imm Enterprises , Ltd.
- Date Received
- January 24, 1984
- Decision Date
- May 9, 1984
- Product Code
- KCP
- 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 |
|---|---|---|---|
| KCP | Syringe, Ent | FDA class 1 | Ear, Nose, Throat |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KCP), ordered by most recent decision date.
EAR/ULCER SYRINGE
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SYRINGE, EAR & ULCER
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Other Clearances by Imm Enterprises , Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K841387 | WESTON RECTAL SNARE | May 9, 1984 | Substantially Equivalent |
| K841386 | KOLLMANN URETHRAL DILATOR | May 9, 1984 | Substantially Equivalent |
| K840304 | CATEGORY 17-MICROBIOLOGY DEVICES | May 1, 1984 | Substantially Equivalent |
| K840318 | CAT. 14-CLINICAL TOXIOLOGY DEVICES | Apr 23, 1984 | Substantially Equivalent |
| K840305 | CATEGORY 1 CIRCULATORY SYSTEM DEVICE | Apr 23, 1984 | Substantially Equivalent |
| K840312 | CAT. 8 DENTAL DEVICES | Apr 5, 1984 | Substantially Equivalent |
| K834171 | OP-CON SURG. INSTRUMENT #3 | Apr 4, 1984 | Substantially Equivalent |
| K834191 | JAKOBI SURGICAL INSTRUMENTS #3 17/18/19 | Mar 22, 1984 | Substantially Equivalent |
| K834192 | JAKOBI SURG. INSTRUMENTS #3 21/22/24 | Mar 22, 1984 | Substantially Equivalent |
| K840310 | CATEGORY 6 OPTHALMIC DEVICES | Mar 16, 1984 | Substantially Equivalent |