510(k) K870809
K870809 is an FDA 510(k) premarket notification submitted by Adept-Med Intl., Inc. for the device "MCNEALY-GLASSMAN VISCERA RETAINER #3202/3204/3206". The FDA issued a decision of Substantially Equivalent on March 19, 1987. The device falls under product code GCZ (Retainer, Surgical), a Class I device regulated under 21 CFR 878.4800. Adept-Med Intl., Inc. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 19, 1987
- Date Received
- March 3, 1987
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Retainer, Surgical
- Device Class
- Class I
- Regulation Number
- 878.4800
- Review Panel
- SU
- Submission Type