FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
P.T.I. DRESSING CHANGE TRAYS
K Number: K833758
·
Decision Jan 26, 1984
Classifications
1
FEI Numbers
11
Registration Numbers
11
Same Product Code
33
Applicant Total
13
Review Days
92
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Basic Information
- Device Name
- P.T.I. DRESSING CHANGE TRAYS
- K Number
- K833758
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.6250
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Packaging Technologies, Inc.
- Date Received
- October 26, 1983
- Decision Date
- January 26, 1984
- Product Code
- FMC
- 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 |
|---|---|---|---|
| FMC | Patient Examination Glove | FDA class 1 | General Hospital |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FMC), ordered by most recent decision date.
LAGLOVE BRAND DOUBLE POLYMER COATED NITRILE EXAMINATION GLOVES (POWDER FREE - BLUE COLOR)
FDA 510(k)
FDA Class 1
·General Hospital
POWDER-FREE LATEX EXAM GLOVES WITH PROTEIN LABELING (<50UG/G)
FDA 510(k)
FDA Class 1
·General Hospital
BLOSSOM POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM 50 MCGM OR LESS OF TOTAL WATER EXTRACTA
FDA 510(k)
FDA Class 1
·General Hospital
NITRILE RUBBER POWDER-FREE EXAMINATION GLOVE
FDA 510(k)
FDA Class 1
·General Hospital
NITRILE RUBBER EXAMINATION GLOVES (POWERED)
FDA 510(k)
FDA Class 1
·General Hospital
SURGICAL INSTRUMENT KIT, DISPOSABLE
FDA 510(k)
FDA Class 1
·General Hospital
Other Clearances by Packaging Technologies, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K881756 | STERILE SURGEONS GLOVES | Jun 1, 1988 | Substantially Equivalent |
| K863326 | BONE MARROW TRAY | Sep 16, 1986 | Substantially Equivalent |
| K861041 | ENHANCE | May 30, 1986 | Substantially Equivalent |
| K850544 | SHAVE PREP TRAY | Mar 12, 1985 | Substantially Equivalent |
| K850438 | RENAL BIOPSY TRAY | Feb 26, 1985 | Substantially Equivalent |
| K844613 | GENERAL PURPOSE INSTRUMENT TRAYS SUTURE REMOVAL TR | Jan 10, 1985 | Substantially Equivalent |
| K844611 | SINGLE BASIN SET | Dec 19, 1984 | Substantially Equivalent |
| K844614 | IV START KIT | Dec 19, 1984 | Substantially Equivalent |
| K844612 | ACUTE HEMODIALYSIS TRAYS | Dec 17, 1984 | Substantially Equivalent |
| K834074 | PERCUTANEOUS SHEATH INTRODUCER TRAY | Mar 19, 1984 | Substantially Equivalent |