FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HYPO SUTURE
K Number: K834138
·
Decision Jan 27, 1984
Classifications
1
FEI Numbers
76
Registration Numbers
76
Same Product Code
41
Applicant Total
10
Review Days
58
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Basic Information
- Device Name
- HYPO SUTURE
- K Number
- K834138
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4740
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Medical Design & Manufacturing Corp.
- Date Received
- November 30, 1983
- Decision Date
- January 27, 1984
- Product Code
- GAG
- 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 |
|---|---|---|---|
| GAG | Stapler, Surgical | FDA class 2 | General Hospital |
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Other Clearances by Medical Design & Manufacturing Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K911911 | MEDICAL DESIGNS, INC. BIO-THERAPY SYSTEM | Mar 20, 1992 | Substantially Equivalent |
| K914384 | MEDICAL DESIGNS REUSABLE CARBON RUBBER ELECTRODE | Nov 13, 1991 | Substantially Equivalent |
| K911366 | PROTECTOR DISPOSABLE TENS AND NMES ELECTRODE | Sep 27, 1991 | Substantially Equivalent |
| K902822 | MEDICAL DESIGNS, INC., SPECTRUM II TENS DEVICE | Dec 19, 1990 | Substantially Equivalent |
| K895604 | SOFT-EZ REUSABLE SELF-ADHERING PIGTAIL ELECTRODES | Oct 13, 1989 | Substantially Equivalent |
| K880492 | INTERCEPT T.E.N.S. DEVICE | Apr 18, 1988 | Substantially Equivalent |
| K821848 | ASSURE-MALE EXTERNAL INCONTINCE CATHETER | Aug 10, 1982 | Substantially Equivalent |
| K811224 | MINISTIM | Jun 2, 1981 | Substantially Equivalent |
| K810222 | LIMB ORHTOSIS | Feb 4, 1981 | Substantially Equivalent |