510(k) K931607
K931607 is an FDA 510(k) premarket notification submitted by Armm, Inc. for the device "MEDDRAINS". The FDA issued a decision of Substantially Equivalent on August 6, 1993. The device falls under product code GBN (Catheter, Pediatric, General & Plastic Surgery), a Class I device regulated under 21 CFR 878.4200. Armm, Inc. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 6, 1993
- Date Received
- April 1, 1993
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Pediatric, General & Plastic Surgery
- Device Class
- Class I
- Regulation Number
- 878.4200
- Review Panel
- SU
- Submission Type