FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ENVICLUSIVE (TM)
K Number: K874554
·
Decision Mar 11, 1988
Classifications
1
FEI Numbers
502
Registration Numbers
502
Same Product Code
106
Applicant Total
38
Review Days
128
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Basic Information
- Device Name
- ENVICLUSIVE (TM)
- K Number
- K874554
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4020
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Marion Laboratories, Inc.
- Date Received
- November 4, 1987
- Decision Date
- March 11, 1988
- Product Code
- NAD
- Advisory Committee
- General, Plastic Surgery
- 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 |
|---|---|---|---|
| NAD | Dressing, Wound, Occlusive | FDA class 1 | General, Plastic Surgery |
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Other Clearances by Marion Laboratories, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K883391 | POLYMER ADHESIVE BANDAGE | Mar 23, 1989 | Substantially Equivalent for Some Indications |
| K875182 | MODIFIED LABELING FOR TOXI-LAB THC SCREEN | Jul 5, 1988 | Substantially Equivalent |
| K875181 | MODIFIED LABELING FOR TOXI-LAB BROAD SPECTRUM | May 27, 1988 | Substantially Equivalent |
| K874551 | ENVINET(TM) | Jan 22, 1988 | Substantially Equivalent for Some Indications |
| K874552 | ENVISAN PAD | Jan 22, 1988 | Substantially Equivalent for Some Indications |
| K874553 | ENVISAN PASTE | Dec 18, 1987 | Substantially Equivalent for Some Indications |
| K870864 | CULTURETTE BRAND CDT CLOSTRIDIUM DIFFICILE TEST | Apr 14, 1987 | Substantially Equivalent |
| K863485 | MODIFICATION OF CDT(TM) CLOSTRIDIUM TEST | Sep 17, 1986 | Substantially Equivalent |
| K862123 | BIOSPHERE ANAEROBIC ENVIRONMENTAL DEVICE | Jun 16, 1986 | Substantially Equivalent |
| K853073 | CULTURETTE BRAND 10-MINUTE GROUP A STREP I.D. | Aug 1, 1985 | Substantially Equivalent |