FDA 510(k)
FDA unclassified
Substantially Equivalent for Some Indications
🇺🇸 United States
KALTOSTAT WOUND DRESSING
K Number: K904488
·
Decision Dec 12, 1990
Classifications
1
FEI Numbers
113
Registration Numbers
113
Same Product Code
126
Applicant Total
19
Review Days
71
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Basic Information
- Device Name
- KALTOSTAT WOUND DRESSING
- K Number
- K904488
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent for Some Indications
- Applicant
- Calgon Vestal Div.
- Date Received
- October 2, 1990
- Decision Date
- December 12, 1990
- Product Code
- QSY
- 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 |
|---|---|---|---|
| QSY | Hemostatic Wound Dressing Without Thrombin Or Other Biologics | FDA unclassified | Unknown |
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Other Clearances by Calgon Vestal Div.
| K Number | Device Name | ||
|---|---|---|---|
| K944494 | ALSA-KLENZ | Oct 19, 1994 | Substantially Equivalent |
| K944033 | BILL EVANS-KLENZ | Oct 7, 1994 | Substantially Equivalent |
| K942270 | SAF-GEL HYDRATING DERMAL WOUND DRESSING | Aug 4, 1994 | Substantially Equivalent |
| K931477 | AMERSE | Jun 17, 1994 | Substantially Equivalent |
| K931816 | VESTA-SYDE(R) INTERIM INSTR DECONTAMINATION SYSTEM | May 26, 1994 | Substantially Equivalent |
| K931342 | LPH | May 26, 1994 | Substantially Equivalent |
| K941163 | MON-KLENZ | May 18, 1994 | Substantially Equivalent |
| K931573 | VESPHENE II | May 16, 1994 | Substantially Equivalent |
| K932277 | LONZA FORMULATION R-82 | May 12, 1994 | Substantially Equivalent |
| K931599 | HYDRASORB STERILE DRESSING | Jul 8, 1993 | Substantially Equivalent |