FDA 510(k)
FDA unclassified
Substantially Equivalent for Some Indications
🇺🇸 United States
SPARTA WET DRESSING, SODIUM CHLORIDE
K Number: K922729
·
Decision Nov 23, 1992
Classifications
1
FEI Numbers
384
Registration Numbers
385
Same Product Code
702
Applicant Total
7
Review Days
171
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Basic Information
- Device Name
- SPARTA WET DRESSING, SODIUM CHLORIDE
- K Number
- K922729
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent for Some Indications
- Applicant
- Sparta Surgical Corp.
- Date Received
- June 5, 1992
- Decision Date
- November 23, 1992
- Product Code
- FRO
- Advisory Committee
- Unknown
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| FRO | Dressing, Wound, Drug | FDA unclassified | Unknown |
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Other Clearances by Sparta Surgical Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K965187 | SPECTRUM II, SPECTRUM PLUS, AND SPECTRUM MAX-SD | Aug 1, 1997 | Substantially Equivalent |
| K945313 | SPARTA HYDROGEL WOUND DRESSING | Jan 12, 1995 | Substantially Equivalent |
| K905384 | DAVID SIMMONDS ANESTHESIA EXTENSION TUBES | Mar 22, 1991 | Substantially Equivalent |
| K905240 | VESSELOOPS | Feb 6, 1991 | Substantially Equivalent |
| K896085 | SURGI-BRUSH | Nov 8, 1989 | Substantially Equivalent |
| K896084 | MICROSPEARS | Nov 2, 1989 | Substantially Equivalent |