FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
EVERT-IT
K Number: K962828
·
Decision Feb 10, 1997
Classifications
1
FEI Numbers
91
Registration Numbers
91
Same Product Code
26
Applicant Total
17
Review Days
206
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Basic Information
- Device Name
- EVERT-IT
- K Number
- K962828
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 884.5150
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Genesis Industries, Inc.
- Date Received
- July 19, 1996
- Decision Date
- February 10, 1997
- Product Code
- HGY
- Advisory Committee
- Obstetrics/Gynecology
- Review Advisory Committee
- OB
- 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 |
|---|---|---|---|
| HGY | Pump, Breast, Non-Powered | FDA class 1 | Obstetrics/Gynecology |
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Other Clearances by Genesis Industries, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K994361 | ESP FOUR WELL TISSUE CULTURE PLATE, ESP SIX WELL TISSUE CULTURE PLATE, ESP MICRO SIX WELL TISSUE CULTURE PLATE, ESP WELL | Feb 18, 2000 | Substantially Equivalent |
| K880377 | NOVO VIVO MODEL #17140 AND #17135 | Apr 4, 1988 | Substantially Equivalent |
| K880376 | NOVO VIVO SUCTION CATHETER VESSEL W/MUCOSE TRAP | Feb 16, 1988 | Substantially Equivalent |
| K833287 | SATIN CAST ECONOCAST | Jan 3, 1984 | Substantially Equivalent |
| K833290 | C & B 40 PENTRO C & B40 | Jan 3, 1984 | Substantially Equivalent |
| K833278 | C & B 45 | Dec 29, 1983 | Substantially Equivalent |
| K833289 | C & B 61 PENTRON C & B61 | Dec 29, 1983 | Substantially Equivalent |
| K833280 | SUPRA AP CHOICE 83 | Dec 26, 1983 | Substantially Equivalent |
| K833285 | RX IV PENTRON IV | Dec 22, 1983 | Substantially Equivalent |
| K833288 | C & B57 PENTRON C & B57 | Dec 20, 1983 | Substantially Equivalent |