FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
HYDRASORB STERILE DRESSING
K Number: K931599
·
Decision Jul 8, 1993
Classifications
1
FEI Numbers
22
Registration Numbers
22
Same Product Code
79
Applicant Total
19
Review Days
98
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Basic Information
- Device Name
- HYDRASORB STERILE DRESSING
- K Number
- K931599
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Calgon Vestal Div.
- Date Received
- April 1, 1993
- Decision Date
- July 8, 1993
- Product Code
- MGP
- 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 |
|---|---|---|---|
| MGP | Dressing, Wound And Burn, Occlusive | FDA unclassified | Unknown |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (MGP), ordered by most recent decision date.
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FASTSEAL CHEST WOUND DRESSING
FDA 510(k)
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SIMPLICARE TRANSPARENT WOUND DRESSING
FDA 510(k)
FDA Unclassified
·Unknown
DERMAPHYLYX SKIN PROTECTORS, PROTECT IT SKIN PROTECTORS
FDA 510(k)
FDA Unclassified
·Unknown
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 |
| K926034 | EPI-LOCK WOUND DRESSING | Apr 20, 1993 | Substantially Equivalent |