FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
DISPOSABLE ABDOMINAL BINDER
K Number: K760772
·
Decision Nov 3, 1976
Classifications
1
FEI Numbers
108
Registration Numbers
108
Same Product Code
4
Applicant Total
35
Review Days
30
Basic Information
- Device Name
- DISPOSABLE ABDOMINAL BINDER
- K Number
- K760772
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.5160
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- TECNOL NEW JERSEY WOUND CARE, INC.
- Date Received
- October 4, 1976
- Decision Date
- November 3, 1976
- Product Code
- FSD
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| FSD | Binder, Abdominal | FDA class 1 | General Hospital |
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Other Clearances by TECNOL NEW JERSEY WOUND CARE, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K913043 | MODIFICATION TECNOL FLUIDSHIELD SURGICAL MASKS | Aug 23, 1991 | Substantially Equivalent |
| K911891 | FLUIDSHIELD(TM) CONE CLASSIC(TM) II SURGICAL MASK | Jul 12, 1991 | Substantially Equivalent |
| K911907 | FLUIDSHIELD CONE CLASSIC II SURG MASK W/SPLASH VIS | Jul 8, 1991 | Substantially Equivalent |
| K896193 | TECNOL LAZER(TM) SURGICAL MASK | Feb 27, 1990 | Substantially Equivalent |
| K894205 | TECNOL SILK STRIP | Jul 25, 1989 | Substantially Equivalent |
| K893702 | TECNOL GAITERS PRODUCT NUMBER 47725-010 | Jun 23, 1989 | Substantially Equivalent |
| K891187 | TECNOL NASO-GASTRIC TUBE HOLDER | May 30, 1989 | Substantially Equivalent |
| K891178 | TECNOL SECURE-ALL TUBE HOLDER | May 23, 1989 | Substantially Equivalent |
| K884440 | TECNOL VARIABLE TENSION BANDAGE | Jan 17, 1989 | Substantially Equivalent for Some Indications |
| K882640 | TECNOL SECURE-ALL PELVIC TRACTION BELT | Jul 27, 1988 | Substantially Equivalent |