FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
BAND-AID BRAND OF ADHESIVE BANDAGES
K Number: K770081
·
Decision Mar 9, 1977
Classifications
1
FEI Numbers
28
Registration Numbers
28
Same Product Code
34
Applicant Total
206
Review Days
54
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Basic Information
- Device Name
- BAND-AID BRAND OF ADHESIVE BANDAGES
- K Number
- K770081
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.5240
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Johnson & Johnson Professionals, Inc.
- Date Received
- January 14, 1977
- Decision Date
- March 9, 1977
- Product Code
- FPX
- Advisory Committee
- General Hospital
- 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 |
|---|---|---|---|
| FPX | Strip, Adhesive, Closure, Skin | FDA class 1 | General Hospital |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FPX), ordered by most recent decision date.
K-KLOSURE 2 INCH LENGTH/4 INCH LENGTH/8 INCH LENGTH/12 INCH LENGTH
FDA 510(k)
FDA Class 1
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DELPORE SKIN CLOSURE
FDA 510(k)
FDA Class 1
·General Hospital
DERMA SEAL
FDA 510(k)
FDA Class 1
·General Hospital
BIOSTRIP STERILE WOUND CLOSURE STRIP
FDA 510(k)
FDA Class 1
·General Hospital
DUKAL SKIN CLOSURE STRIP
FDA 510(k)
FDA Class 1
·General Hospital
SPYROFLEX WOUND CLOSURES
FDA 510(k)
FDA Class 1
·General Hospital
Other Clearances by Johnson & Johnson Professionals, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K992173 | SIPHONGUARD CSF CONTROL DEVICE | Apr 7, 2000 | Substantially Equivalent |
| K991413 | CODMAN ETHISORB DURA PATCH | Mar 13, 2000 | Substantially Equivalent |
| K991222 | CODMAN MICROSENSOR VENTRICULAR CATHETER KIT | Jul 9, 1999 | Substantially Equivalent |
| K982379 | SUNDT SLIM-LINE ANEURYSM CLIP APPLIER | Dec 18, 1998 | Substantially Equivalent |
| K982812 | G2 TOTAL HIP SYSTEM FEMORAL STEM (11/13 TAPER) | Dec 4, 1998 | Substantially Equivalent |
| K983141 | CAPITELLO-CONDYLAR TOTAL ELBOW PROSTHESIS | Nov 6, 1998 | Substantially Equivalent |
| K983014 | SUMMIT ACETABULAR SYSTEM | Oct 27, 1998 | Substantially Equivalent |
| K980778 | HAKIM MICRO PROGRAMMABLE VALVE SYSTEM | Jul 17, 1998 | Substantially Equivalent |
| K974739 | HAKIM PROGRAMMABLE VALVE SYSTEM | Jul 1, 1998 | Substantially Equivalent |
| K980801 | J-FX BIPOLAR HEAD | May 29, 1998 | Substantially Equivalent |