510(k) K771011
K771011 is an FDA 510(k) premarket notification submitted by Parker Laboratories, Inc. for the device "ARTICULATING PAPER". The FDA issued a decision of Substantially Equivalent on Jun 20, 1977. The device falls under product code EFH (Paper, Articulation), a Class I device regulated under 21 CFR 872.6140. Parker Laboratories, Inc. has 29 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jun 20, 1977
- Date Received
- Jun 6, 1977
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Paper, Articulation
- Device Class
- Class I
- Regulation Number
- 872.6140
- Review Panel
- DE
- Submission Type
- 510(k) Exempt