Submission Details
| 510(k) Number | K771791 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 22, 1977 |
| Decision Date | October 04, 1977 |
| Days to Decision | 12 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | — |
Cleared
Traditional
K771791 - NEEDLE COUNTING
(FDA 510(k) Clearance)
Oct 1977
Decision
12d
Days
Class 2
Risk
K771791 is an FDA 510(k) clearance for the NEEDLE COUNTING. This device is classified as a Container, Sharps (Class II — Special Controls, product code MMK).
Submitted by Chase Mfg. Co. (Mchenry, US). The FDA issued a Cleared decision on October 4, 1977, 12 days after receiving the submission on September 22, 1977.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5570.
Device Classification
| Product Code | MMK — Container, Sharps |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 880.5570 |
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