510(k) K832525
K832525 is an FDA 510(k) premarket notification submitted by Intermedics Intraocular, Inc. for the device "IRRIGATION/ASPIRATION PACK". The FDA issued a decision of Substantially Equivalent on October 4, 1983. Intermedics Intraocular, Inc. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 4, 1983
- Date Received
- July 29, 1983
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No