FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PROLONG, MODELS PL50, PL100, PL150
K Number: K001129
·
Decision Jul 6, 2000
Classifications
1
FEI Numbers
81
Registration Numbers
81
Same Product Code
154
Applicant Total
68
Review Days
90
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Basic Information
- Device Name
- PROLONG, MODELS PL50, PL100, PL150
- K Number
- K001129
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5140
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Life-Tech Intl., Inc.
- Date Received
- April 7, 2000
- Decision Date
- July 6, 2000
- Product Code
- CAZ
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- AN
- 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 |
|---|---|---|---|
| CAZ | Anesthesia Conduction Kit | FDA class 2 | Anesthesiology |
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|---|---|---|---|
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| K953451 | UROPUMP TUBE & DAMPING CHAMGER | Oct 5, 1995 | Substantially Equivalent |
| K953353 | UROVISION JANUS | Sep 8, 1995 | Substantially Equivalent |
| K946108 | EAR-A-GATOR | Jun 13, 1995 | Substantially Equivalent |
| K913601 | MICROPHOR | Jul 15, 1994 | Substantially Equivalent |
| K940203 | TRIPLE LUMEN URODYNAMIC CATHETER WITH RADIOPAQUE MARKERS | Mar 30, 1994 | Substantially Equivalent |
| K931179 | UROLAB SPECTRUM | Nov 18, 1993 | Substantially Equivalent |