FDA 510(k)
Substantially Equivalent
🇺🇸 United States
BARIUM ENEMAS
K Number: K828661
·
Decision Jan 17, 1983
Classifications
0
FEI Numbers
0
Registration Numbers
0
Same Product Code
0
Applicant Total
2
Review Days
63
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Basic Information
- Device Name
- BARIUM ENEMAS
- K Number
- K828661
- Clearance Type
- Traditional
- Decision
- Substantially Equivalent
- Applicant
- The Healthcare Group, Inc.
- Date Received
- November 15, 1982
- Decision Date
- January 17, 1983
- Advisory Committee
- Unknown
- Review Advisory Committee
- RA
- Third Party
- N
Other Clearances by The Healthcare Group, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K902795 | MODIFIED CHAIRS (DENTAL, MEDICAL, AND PODIATRY) | Jul 25, 1990 | Substantially Equivalent |