FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
PAREMA K BAND NON-STERILE
K Number: K833867
·
Decision Jan 27, 1984
Classifications
1
FEI Numbers
59
Registration Numbers
59
Same Product Code
270
Applicant Total
5
Review Days
81
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Basic Information
- Device Name
- PAREMA K BAND NON-STERILE
- K Number
- K833867
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Applicant
- Mark One Healthcare Products
- Date Received
- November 7, 1983
- Decision Date
- January 27, 1984
- Product Code
- EFQ
- 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 |
|---|---|---|---|
| EFQ | Gauze/Sponge, Internal | FDA unclassified | Unknown |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (EFQ), ordered by most recent decision date.
NON-ABSORBABLE GAUZE FOR EXTERNAL USE, STERILE AND NON STERILE
FDA 510(k)
FDA Unclassified
·Unknown
SYMTEX GAUZE PADS (1'S) AND SYMTEX GAUZE SPONGES STERILE 2'S AND STERILE 10'S
FDA 510(k)
FDA Unclassified
·Unknown
VITOP DRESSING
FDA 510(k)
FDA Unclassified
·Unknown
GAUZE SPONGES: LAPAROTOMY SPONGE, X-RAY DETECTABLE
FDA 510(k)
FDA Unclassified
·Unknown
CROSSTEX NON-WOVEN SPONGES
FDA 510(k)
FDA Unclassified
·Unknown
GAUZE, SPONGES, CAT # 11-003
FDA 510(k)
FDA Unclassified
·Unknown
Other Clearances by Mark One Healthcare Products
| K Number | Device Name | ||
|---|---|---|---|
| K891986 | MULTIPLE-VARIOUS TYPES OF ABSORBENT INCONTINENCE | Dec 29, 1989 | Substantially Equivalent |
| K833084 | MASTERHINGE | Oct 14, 1983 | Substantially Equivalent |
| K770396 | DRAPES, MODESTY | Mar 23, 1977 | Substantially Equivalent |
| K761268 | SKIN PRESSURE PROTECTORS | Feb 16, 1977 | Substantially Equivalent |