FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ENTERAL ADMINISTRATION SET
K Number: K870623
·
Decision Jun 26, 1987
Classifications
1
FEI Numbers
46
Registration Numbers
47
Same Product Code
58
Applicant Total
16
Review Days
134
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Basic Information
- Device Name
- ENTERAL ADMINISTRATION SET
- K Number
- K870623
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5980
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Plasco, Inc.
- Date Received
- February 12, 1987
- Decision Date
- June 26, 1987
- Product Code
- FPD
- 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 |
|---|---|---|---|
| FPD | Tube, Feeding | FDA class 2 | Gastroenterology, Urology |
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NUTRISAFE 2 FEEDING TUBES MODEL 362.XXX. 1362.XXX
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·Gastroenterology, Urology
Other Clearances by Plasco, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K980066 | CPR FILTERSHIELD | Jul 16, 1998 | Substantially Equivalent |
| K953414 | CPR MICROMASK WITH OXYGEN INLET | Mar 20, 1996 | Substantially Equivalent |
| K951483 | CPR MICROMASK | Oct 19, 1995 | Substantially Equivalent |
| K950769 | CPR MICROMASK PLUS CATALOG NO 73-402 | Mar 10, 1995 | Substantially Equivalent |
| K950770 | CPR MICROSHIELD II | Mar 10, 1995 | Substantially Equivalent |
| K943386 | CPR MICROMASK | Feb 21, 1995 | Substantially Equivalent |
| K932649 | PHARMAFEED | Nov 16, 1993 | Substantially Equivalent |
| K880337 | MACBICK DISPOSABLE BARIUM ENEMA SYST 4800 & 4700 | Apr 14, 1988 | Substantially Equivalent |
| K870019 | THE LAHR BALLOON | Apr 1, 1987 | Substantially Equivalent |
| K870796 | MACBICK-XL BASIC AIR CONTAST BARIUM ENEMA DELIV SY | Apr 1, 1987 | Substantially Equivalent |