FDA 510(k)
Substantially Equivalent
🇺🇸 United States
STERILE LASER RESISTANT SURGICAL FIELD DRAPE
K Number: K854266
·
Decision Mar 27, 1986
Classifications
0
FEI Numbers
0
Registration Numbers
0
Same Product Code
0
Applicant Total
3
Review Days
155
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
- STERILE LASER RESISTANT SURGICAL FIELD DRAPE
- K Number
- K854266
- Clearance Type
- Traditional
- Decision
- Substantially Equivalent
- Applicant
- Lasersafe, Inc.
- Date Received
- October 23, 1985
- Decision Date
- March 27, 1986
- Advisory Committee
- Unknown
- Review Advisory Committee
- SU
- Third Party
- N