FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DYNAPHOR(TM) TWO
K Number: K935868
·
Decision Mar 15, 1995
Classifications
1
FEI Numbers
20
Registration Numbers
20
Same Product Code
72
Applicant Total
26
Review Days
464
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Basic Information
- Device Name
- DYNAPHOR(TM) TWO
- K Number
- K935868
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.5525
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Maxxim Medical
- Date Received
- December 6, 1993
- Decision Date
- March 15, 1995
- Product Code
- EGJ
- Advisory Committee
- Physical Medicine
- Review Advisory Committee
- PM
- 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 |
|---|---|---|---|
| EGJ | Device, Iontophoresis, Other Uses | FDA class 2 | Physical Medicine |
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| K002933 | STERILE SENSICARE SYNTHETIC POLYISOPRENE POWDER-FREE SURGICAL GLOVES | Oct 19, 2000 | Substantially Equivalent |
| K990173 | PATHFINDER II ANGIOGRAPHIC CATHETER | Dec 21, 1999 | Substantially Equivalent |
| K992865 | SENSICARE XP VINYL POWDER FREE MEDICAL EXAMINATION GLOVE | Oct 13, 1999 | Substantially Equivalent |
| K991615 | POLYURETHANE POWDER FREE DENTAL EXAMINATION GLOVE, POLYURETHANE POWDER FREE MEDICAL EXAMINATION GLOVE | Jul 30, 1999 | Substantially Equivalent |
| K992122 | TRU-TOUCH PF VINYL POWDER FREE EXAMINATION GLOVE | Jul 15, 1999 | Substantially Equivalent |