FDA 510(k)
Substantially Equivalent
🇺🇸 United States
PENROSE DRAINS
K Number: K841037
·
Decision Apr 25, 1984
Classifications
0
FEI Numbers
0
Registration Numbers
0
Same Product Code
0
Applicant Total
32
Review Days
44
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Basic Information
- Device Name
- PENROSE DRAINS
- K Number
- K841037
- Clearance Type
- Traditional
- Decision
- Substantially Equivalent
- Applicant
- Inmed Corp.
- Date Received
- March 12, 1984
- Decision Date
- April 25, 1984
- Advisory Committee
- Unknown
- Review Advisory Committee
- SU
- Third Party
- N
Other Clearances by Inmed Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K862672 | ESOPHAGEAL STETHOSCOPE WITH THERMISTOR | Oct 27, 1986 | Substantially Equivalent |
| K853162 | STERILE NASOPHARYNGEAL AIRWAY | Aug 6, 1985 | Substantially Equivalent |
| K850152 | PRECONNECTED URETHRAL CATHETER TRAY | Mar 12, 1985 | Substantially Equivalent |
| K850335 | URETEROSCOPY CATHETER | Mar 12, 1985 | Substantially Equivalent |
| K850248 | DISPOSABLE GUEDEL AIRWAY | Mar 12, 1985 | Substantially Equivalent |
| K844801 | ULTRA EXTERNAL CATHETER | Jan 15, 1985 | Substantially Equivalent |
| K842301 | DISPOSABLE LATEX BANDAGE | Nov 5, 1984 | Substantially Equivalent |
| K842866 | URETHRAL CATHETERIZATION TRAY | Sep 10, 1984 | Substantially Equivalent |
| K841040 | FOX POST NASAL BALLOON CATHETER | Aug 17, 1984 | Substantially Equivalent |
| K842865 | ESOPHAGEAL STETHOSCOPE | Aug 15, 1984 | Substantially Equivalent |