510(k) K942789
K942789 is an FDA 510(k) premarket notification submitted by The Merlin Corp. for the device "MISTASSIST". The FDA issued a decision of Substantially Equivalent on August 12, 1994. The device falls under product code LRD (Applicator, Ent Drug), a Class I device regulated under 21 CFR 874.5220. The Merlin Corp. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 12, 1994
- Date Received
- June 14, 1994
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Applicator, Ent Drug
- Device Class
- Class I
- Regulation Number
- 874.5220
- Review Panel
- EN
- Submission Type