FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
TECNOL STIRRUPS STRAP
K Number: K791859
·
Decision Oct 4, 1979
Classifications
1
FEI Numbers
151
Registration Numbers
151
Same Product Code
19
Applicant Total
35
Review Days
16
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Basic Information
- Device Name
- TECNOL STIRRUPS STRAP
- K Number
- K791859
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4950
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Tecnol New Jersey Wound Care, Inc.
- Date Received
- September 18, 1979
- Decision Date
- October 4, 1979
- Product Code
- BWN
- 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 |
|---|---|---|---|
| BWN | Table And Attachments, Operating-Room | FDA class 1 | General, Plastic Surgery |
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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 |