510(k) K896621
K896621 is an FDA 510(k) premarket notification submitted by Intl. Medical Marketing, Inc. for the device "L.T.C. REPLACEMENT GASTROSTOMY TUBE". The FDA issued a decision of Substantially Equivalent on March 13, 1990. The device falls under product code KCQ (Tube Impression And Matrix), a Class I device regulated under 21 CFR 872.6570. Intl. Medical Marketing, Inc. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 13, 1990
- Date Received
- November 21, 1989
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Tube Impression And Matrix
- Device Class
- Class I
- Regulation Number
- 872.6570
- Review Panel
- DE
- Submission Type