FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
SPARTA HYDROGEL WOUND DRESSING
K Number: K945313
·
Decision Jan 12, 1995
Classifications
1
FEI Numbers
51
Registration Numbers
51
Same Product Code
144
Applicant Total
7
Review Days
72
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Basic Information
- Device Name
- SPARTA HYDROGEL WOUND DRESSING
- K Number
- K945313
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Sparta Surgical Corp.
- Date Received
- November 1, 1994
- Decision Date
- January 12, 1995
- Product Code
- MGQ
- 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 |
|---|---|---|---|
| MGQ | Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic | 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 |
| K922729 | SPARTA WET DRESSING, SODIUM CHLORIDE | Nov 23, 1992 | Substantially Equivalent for Some Indications |
| 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 |