FDA 510(k)
FDA unclassified
Substantially Equivalent
🇬🇧 United Kingdom
TRANSPARENT FILM DRESSING, INTELLIGENT FILM DRESSING
K Number: K973312
·
Decision Oct 22, 1997
Classifications
1
FEI Numbers
22
Registration Numbers
22
Same Product Code
79
Applicant Total
14
Review Days
49
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Basic Information
- Device Name
- TRANSPARENT FILM DRESSING, INTELLIGENT FILM DRESSING
- K Number
- K973312
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Innovative Technologies , Ltd.
- Date Received
- September 3, 1997
- Decision Date
- October 22, 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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Other Clearances by Innovative Technologies , Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K983303 | INNOVATIVE TECHNOLOGIES HYDROCOLLOID AND INTELLIGENT HYDROCOLLOID WOUND DRESSINGS | Dec 9, 1998 | Substantially Equivalent |
| K982234 | AL-GEN CALCIUM ALGINATE DRESSING | Sep 8, 1998 | Substantially Equivalent |
| K982638 | 3M TEGAGEN HI ALGINATE DRESSING & 3 M TEGAGEN HG ALGINATE DRESSING, MODEL #'S 90110,90112,90114,90120, 90210,90212,90214 | Aug 21, 1998 | Substantially Equivalent |
| K981753 | INNOVATIVE TECHNOLOGIES TRANSPARENT FILM AND INTELLIGENT FILM WOUND DRESSING | Jun 30, 1998 | Substantially Equivalent |
| K980989 | 3M TEGAGEN HI ALGINATE DRESSING & 3M TEGAGEN HG ALGINATE DRESSING | May 27, 1998 | Substantially Equivalent |
| K980097 | FLEXIGEL-G HYDROGEL WOUND DRESSING | Mar 4, 1998 | Substantially Equivalent |
| K973855 | IT HYDROCOLLOID WITH ZINC | Dec 1, 1997 | Substantially Equivalent for Some Indications |
| K973283 | ALGINATE/ZINC WOUND DRESSING | Oct 21, 1997 | Substantially Equivalent for Some Indications |
| K971126 | HYDROCOLLOID WOUND DRESSINGS | Jun 24, 1997 | Substantially Equivalent |
| K963598 | INNOVATIVE TECHNOLOGIES ALIGINATE/PECTIN WOUND DRESSINGS | Nov 27, 1996 | Substantially Equivalent |