510(k) K931772
K931772 is an FDA 510(k) premarket notification submitted by Western M/D, Inc. for the device "SURETIP SYRINGE TIP COVER". The FDA issued a decision of Substantially Equivalent on March 7, 1994. The device falls under product code ECB (Unit, Syringe, Air And/Or Water), a Class I device regulated under 21 CFR 872.4565. Western M/D, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 7, 1994
- Date Received
- April 9, 1993
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Unit, Syringe, Air And/Or Water
- Device Class
- Class I
- Regulation Number
- 872.4565
- Review Panel
- DE
- Submission Type