FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
SPYROFLEX PIGMENTED WOUND DRESSING/SPYROFLEX WOUND DRESSING TINTED
K Number: K964398
·
Decision Oct 24, 1997
Classifications
1
FEI Numbers
22
Registration Numbers
22
Same Product Code
79
Applicant Total
16
Review Days
354
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Basic Information
- Device Name
- SPYROFLEX PIGMENTED WOUND DRESSING/SPYROFLEX WOUND DRESSING TINTED
- K Number
- K964398
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Polymedica Industries, Inc.
- Date Received
- November 4, 1996
- Decision Date
- October 24, 1997
- 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 |
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FDA 510(k)
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Other Clearances by Polymedica Industries, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| 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 |
| 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 |