FDA 510(k)
FDA unclassified
Substantially Equivalent for Some Indications
🇺🇸 United States
SPYROCOLLOID WOUND DRESSING
K Number: K955383
·
Decision Dec 13, 1995
Classifications
1
FEI Numbers
22
Registration Numbers
22
Same Product Code
79
Applicant Total
16
Review Days
19
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Basic Information
- Device Name
- SPYROCOLLOID WOUND DRESSING
- K Number
- K955383
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent for Some Indications
- Applicant
- Polymedica Industries, Inc.
- Date Received
- November 24, 1995
- Decision Date
- December 13, 1995
- 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.
COLLATEK FOAM
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LASERSKIN DRESSING
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FASTSEAL CHEST WOUND DRESSING
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SIMPLICARE TRANSPARENT WOUND DRESSING
FDA 510(k)
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DERMAPHYLYX SKIN PROTECTORS, PROTECT IT SKIN PROTECTORS
FDA 510(k)
FDA Unclassified
·Unknown
Other Clearances by Polymedica Industries, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K964398 | SPYROFLEX PIGMENTED WOUND DRESSING/SPYROFLEX WOUND DRESSING TINTED | Oct 24, 1997 | Substantially Equivalent |
| K971045 | BASIS FLEXIBLE TIP DIGITAL THERMOMETER | May 2, 1997 | Substantially Equivalent |
| K964701 | MITRAFLEX PIGMENTED WOUND DRESSING | Feb 7, 1997 | Substantially Equivalent |
| K963623 | SPYROFLEX PIGMENTED WOUND DRESSING | Oct 25, 1996 | Substantially Equivalent |
| K962991 | BASIS BABY-TEMP PACIFIER DIGITAL THEROMETER | Sep 12, 1996 | Substantially Equivalent |
| K953885 | SPYROFLEX SKIN PROTECTOR | Nov 29, 1995 | Substantially Equivalent |
| K952756 | MEDI-AID BASAL THERMOMETER | Sep 25, 1995 | Substantially Equivalent |
| K952159 | BASIS DIGITAL THERMOMETER | Sep 22, 1995 | Substantially Equivalent |
| K953618 | SPYROFLEX WOUND DRESSING | Aug 21, 1995 | Substantially Equivalent for Some Indications |
| K951862 | A GEL WOUND DRESSING | Jul 12, 1995 | Substantially Equivalent |