FDA 510(k)
Substantially Equivalent
🇺🇸 United States
SURGI-TIE LOOPS
K Number: K861161
·
Decision Jun 10, 1986
Classifications
0
FEI Numbers
0
Registration Numbers
0
Same Product Code
0
Applicant Total
2
Review Days
74
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- SURGI-TIE LOOPS
- K Number
- K861161
- Clearance Type
- Traditional
- Decision
- Substantially Equivalent
- Applicant
- Healthmed Corp.
- Date Received
- March 28, 1986
- Decision Date
- June 10, 1986
- Advisory Committee
- Unknown
- Review Advisory Committee
- SU
- Third Party
- N
Other Clearances by Healthmed Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K890006 | BAXTER STERILE TOWEL | Jan 24, 1989 | Substantially Equivalent |