FDA 510(k)
FDA class 2
Unknown
🇺🇸 United States
ARGYLE TURKEL SAFETY PARACENTESIS PROCEDURE TRAY
K Number: K935238
·
Decision Feb 17, 1994
Classifications
1
FEI Numbers
203
Registration Numbers
203
Same Product Code
316
Applicant Total
191
Review Days
108
Basic Information
- Device Name
- ARGYLE TURKEL SAFETY PARACENTESIS PROCEDURE TRAY
- K Number
- K935238
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.6850
- Medical Specialty
- General Hospital
- Decision
- Unknown
- Statement or Summary
- Summary
- Applicant
- SHERWOOD MEDICAL CO.
- Date Received
- November 1, 1993
- Decision Date
- February 17, 1994
- Product Code
- FRG
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| FRG | Wrap, Sterilization | FDA class 2 | General Hospital |
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Other Clearances by SHERWOOD MEDICAL CO.
| K Number | Device Name | ||
|---|---|---|---|
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| K954429 | KANGAROO ENTRISTAR SKIN-LEVEL GASTROSTOMY KIT | Mar 8, 1996 | Unknown |
| K954525 | SENSI-TOUCH EPIDURAL ANESTHESIA FILTER | Jan 19, 1996 | Substantially Equivalent |
| K950201 | ARGYLE(R) HYDROPHILIC COATED THORACIC CATHETER | Dec 15, 1995 | Substantially Equivalent |