510(k) K873440
K873440 is an FDA 510(k) premarket notification submitted by Allegheny Plastics, Inc. for the device "RULE, PUPILLARY". The FDA issued a decision of Substantially Equivalent on September 21, 1987. The device falls under product code HMM (Distometer), a Class I device regulated under 21 CFR 886.1190.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 21, 1987
- Date Received
- August 27, 1987
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Distometer
- Device Class
- Class I
- Regulation Number
- 886.1190
- Review Panel
- OP
- Submission Type