K771011 is an FDA 510(k) clearance for the ARTICULATING PAPER. This device is classified as a Paper, Articulation (Class I - General Controls, product code EFH).
Submitted by Parker Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 20, 1977, 14 days after receiving the submission on June 6, 1977.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.6140.
| 510(k) Number | K771011 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 06, 1977 |
| Decision Date | June 20, 1977 |
| Days to Decision | 14 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | — |
| Product Code | EFH — Paper, Articulation |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 872.6140 |