510(k) K842512
K842512 is an FDA 510(k) premarket notification submitted by Ardent Intl., Inc. for the device "EXACTA-FILM". The FDA issued a decision of Substantially Equivalent - Postmarket Surveillance Required on Jun 27, 1984. Ardent Intl., Inc. has 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESP (Substantially Equivalent - Postmarket Surveillance Required)
- Decision Date
- Jun 27, 1984
- Date Received
- Jun 27, 1984
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No