FDA 510(k)
Substantially Equivalent
🇺🇸 United States
GLYCERINE DEHYDRATION UNIT
K Number: K810400
·
Decision Aug 25, 1981
Classifications
0
FEI Numbers
0
Registration Numbers
0
Same Product Code
0
Applicant Total
2
Review Days
188
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Basic Information
- Device Name
- GLYCERINE DEHYDRATION UNIT
- K Number
- K810400
- Clearance Type
- Traditional
- Decision
- Substantially Equivalent
- Applicant
- Xytex Corp.
- Date Received
- February 18, 1981
- Decision Date
- August 25, 1981
- Advisory Committee
- Unknown
- Review Advisory Committee
- OP
- Third Party
- N
Other Clearances by Xytex Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K821170 | CORNEA PERSERVATION UNIT | Jul 14, 1982 | Substantially Equivalent |