FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
YIELD NON-ADHERENT DRESSING
K Number: K830825
·
Decision May 13, 1983
Classifications
1
FEI Numbers
384
Registration Numbers
385
Same Product Code
702
Applicant Total
9
Review Days
59
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Basic Information
- Device Name
- YIELD NON-ADHERENT DRESSING
- K Number
- K830825
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Applicant
- Professional Medical Products, Inc.
- Date Received
- March 15, 1983
- Decision Date
- May 13, 1983
- Product Code
- FRO
- Advisory Committee
- Unknown
- 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 |
|---|---|---|---|
| FRO | Dressing, Wound, Drug | FDA unclassified | Unknown |
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Other Clearances by Professional Medical Products, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K926280 | STANDARD NEBULIZER HEATER | Mar 22, 1994 | Substantially Equivalent |
| K930270 | PATIENT PREOPERATIVE PREP TRAY, SINGLE USE | Feb 17, 1994 | Substantially Equivalent |
| K920292 | VARIOUS KITS AND TRAYS | Jan 26, 1994 | Unknown |
| K862010 | CHICK SURGICAL LIGHT | Jun 9, 1986 | Substantially Equivalent |
| K860739 | CHICK SURIGICAL LIGHT | Mar 28, 1986 | Substantially Equivalent |
| K834478 | CHICK/REISON PATIENT EMERG. TROLLEY | Feb 21, 1984 | Substantially Equivalent |
| K822713 | DERM-A-TEC SKIN BARRIER FILM | Dec 7, 1982 | Substantially Equivalent |
| K820413 | AEGIS NON-ADHERENT DRESSING | Mar 12, 1982 | Substantially Equivalent |