510(k) K810654
K810654 is an FDA 510(k) premarket notification submitted by First Industries, Inc. for the device "STOPPERLESS HOT/COLD RUBBER WATER BOTTLE". The FDA issued a decision of Substantially Equivalent on Mar 27, 1981. The device falls under product code FDF (Colonoscope And Accessories, Flexible/Rigid), a Class II device regulated under 21 CFR 876.1500. First Industries, Inc. has 5 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Mar 27, 1981
- Date Received
- Mar 10, 1981
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Colonoscope And Accessories, Flexible/Rigid
- Device Class
- Class II
- Regulation Number
- 876.1500
- Review Panel
- GU
- Submission Type
- 510(k)
To examine or perform procedures in the colon or rectum For reusable, flexible endoscopes in this product code, validated reprocessing instructions and reprocessing validation data must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).