FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
SPYROFLEX SKIN PROTECTOR
K Number: K953885
·
Decision Nov 29, 1995
Classifications
1
FEI Numbers
22
Registration Numbers
22
Same Product Code
79
Applicant Total
16
Review Days
104
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Basic Information
- Device Name
- SPYROFLEX SKIN PROTECTOR
- K Number
- K953885
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Polymedica Industries, Inc.
- Date Received
- August 17, 1995
- Decision Date
- November 29, 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
FDA 510(k)
FDA Unclassified
·Unknown
COLLATEK SHEET
FDA 510(k)
FDA Unclassified
·Unknown
LASERSKIN DRESSING
FDA 510(k)
FDA Unclassified
·Unknown
FASTSEAL CHEST WOUND DRESSING
FDA 510(k)
FDA Unclassified
·Unknown
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 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 |
| K955383 | SPYROCOLLOID WOUND DRESSING | Dec 13, 1995 | Substantially Equivalent for Some Indications |
| 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 |