510(k) K771266
K771266 is an FDA 510(k) premarket notification submitted by Amsco Hospital Products Co. for the device "STEAM STERILIZER". The FDA issued a decision of Substantially Equivalent on August 2, 1977. The device falls under product code ECG (Sterilizer, Boiling Water), a Class I device regulated under 21 CFR 872.6710.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 2, 1977
- Date Received
- July 13, 1977
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Sterilizer, Boiling Water
- Device Class
- Class I
- Regulation Number
- 872.6710
- Review Panel
- DE
- Submission Type