510(k) K903209
K903209 is an FDA 510(k) premarket notification submitted by Adler Instrument Co. for the device "MAXI-FLOW INSUFFLATOR TUBING SET W/FILTER". The FDA issued a decision of Substantially Equivalent on December 21, 1990. The device falls under product code HES (Insufflator, Carbon-Dioxide, Uterotubal (And Accessories)), a Class II device regulated under 21 CFR 884.1300. Adler Instrument Co. has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 21, 1990
- Date Received
- July 20, 1990
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Insufflator, Carbon-Dioxide, Uterotubal (And Accessories)
- Device Class
- Class II
- Regulation Number
- 884.1300
- Review Panel
- OB
- Submission Type