FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
KOLLMANN URETHRAL DILATOR
K Number: K841386
·
Decision May 9, 1984
Classifications
1
FEI Numbers
68
Registration Numbers
68
Same Product Code
26
Applicant Total
52
Review Days
43
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Basic Information
- Device Name
- KOLLMANN URETHRAL DILATOR
- K Number
- K841386
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5520
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Imm Enterprises , Ltd.
- Date Received
- March 27, 1984
- Decision Date
- May 9, 1984
- Product Code
- KOE
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- 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 |
|---|---|---|---|
| KOE | Dilator, Urethral | FDA class 2 | Gastroenterology, Urology |
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| 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 |