FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
BANDAGES CATALOG NUMBER: 101 TO 220
K Number: K871495
·
Decision May 8, 1987
Classifications
1
FEI Numbers
502
Registration Numbers
502
Same Product Code
106
Applicant Total
41
Review Days
22
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Basic Information
- Device Name
- BANDAGES CATALOG NUMBER: 101 TO 220
- K Number
- K871495
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4020
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- I M, Inc.
- Date Received
- April 16, 1987
- Decision Date
- May 8, 1987
- 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 I M, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K914600 | NEUROLOGICAL SPONGE | Dec 30, 1992 | Substantially Equivalent |
| K892389 | BIOPSY KIT | Jul 17, 1989 | Unknown |
| K881363 | SYRINGE PREFILLED WITH WATER | Jun 23, 1988 | Substantially Equivalent |
| K880753 | UMBILICAL CORD CLAMP | Apr 27, 1988 | Substantially Equivalent |
| K872741 | NUTRIPUMP | Oct 20, 1987 | Substantially Equivalent |
| K863785 | MAKLER CATHETER | Dec 11, 1986 | Substantially Equivalent |
| K854155 | STERILE SALINE SOLUTION | Dec 10, 1985 | Substantially Equivalent |
| K853287 | HUBOUT | Oct 17, 1985 | Substantially Equivalent |
| K853288 | FEEDING UNITS & TUBES | Oct 4, 1985 | Substantially Equivalent |
| K853286 | STAPLE REMOVER | Aug 21, 1985 | Substantially Equivalent |