FDA 510(k)
FDA not classified
Unknown
🇺🇸 United States
VARIOUS KITS
K Number: K931634
·
Decision Nov 30, 1993
Classifications
1
FEI Numbers
142
Registration Numbers
142
Same Product Code
14
Applicant Total
5
Review Days
243
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Basic Information
- Device Name
- VARIOUS KITS
- K Number
- K931634
- Device Class
- FDA not classified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Unknown
- Statement or Summary
- Statement
- Applicant
- Polymint Industrial Co. , Ltd.
- Date Received
- April 1, 1993
- Decision Date
- November 30, 1993
- Product Code
- LRR
- 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 |
|---|---|---|---|
| LRR | First Aid Kit With Drug | FDA not classified | Unknown |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LRR), ordered by most recent decision date.
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SHAWNEE PRODUCTS KIT I
FDA 510(k)
FDA Not Classified
·Unknown
Other Clearances by Polymint Industrial Co. , Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K932457 | SPYROGEL WOUND DRESSING | Feb 9, 1994 | Substantially Equivalent for Some Indications |
| K921775 | SPYROFLEX WOUND CLOSURES | May 19, 1992 | Substantially Equivalent |
| K911649 | MITRASHEER TRANSPLANT DRESSING | Aug 7, 1991 | Substantially Equivalent |
| K891644 | SAMBORD LATEX PATIENT EXAMINATION GLOVES | Jun 19, 1989 | Substantially Equivalent |