510(k) K955661
K955661 is an FDA 510(k) premarket notification submitted by Glederer & Co., Inc. for the device "ACU-HALT". The FDA issued a decision of Substantially Equivalent on December 30, 1996. Glederer & Co., Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 30, 1996
- Date Received
- December 12, 1995
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No