510(k) K882575
K882575 is an FDA 510(k) premarket notification submitted by Hagg-Streit Service, Inc. for the device "DISTOMETER". The FDA issued a decision of Substantially Equivalent on July 1, 1988. The device falls under product code HMM (Distometer), a Class I device regulated under 21 CFR 886.1190. Hagg-Streit Service, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 1, 1988
- Date Received
- June 22, 1988
- 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