510(k) K772366
K772366 is an FDA 510(k) premarket notification submitted by Atlantic Surgical for the device "BAG, DRAINAGEW/ADHESIVE; PROSTHESIS". The FDA issued a decision of Substantially Equivalent on January 26, 1978. The device falls under product code FON (Bag, Drainage, With Adhesive, Ostomy), a Class I device regulated under 21 CFR 876.5900. Atlantic Surgical has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 26, 1978
- Date Received
- December 27, 1977
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Bag, Drainage, With Adhesive, Ostomy
- Device Class
- Class I
- Regulation Number
- 876.5900
- Review Panel
- GU
- Submission Type