510(k) K083042
K083042 is an FDA 510(k) premarket notification submitted by Nurse Assist, Inc. for the device "WOUND FLUSH, STERILE WATER & NORMAL SALINE". The FDA issued a decision of Substantially Equivalent on December 18, 2008. The device falls under product code FRO (Dressing, Wound, Drug), a Class U device. Nurse Assist, Inc. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 18, 2008
- Date Received
- October 14, 2008
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Dressing, Wound, Drug
- Device Class
- Class U
- Regulation Number
- Review Panel
- SU
- Submission Type