510(k) K942519
K942519 is an FDA 510(k) premarket notification submitted by Bull Frog Mfg. Co. for the device "UNI-SYRINGE, UNI-TIP AND ACCESS SYRINGE TIPS". The FDA issued a decision of Substantially Equivalent on August 23, 1994. The device falls under product code ECB (Unit, Syringe, Air And/Or Water), a Class I device regulated under 21 CFR 872.4565. Bull Frog Mfg. Co. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 23, 1994
- Date Received
- May 26, 1994
- 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