510(k) K810653
K810653 is an FDA 510(k) premarket notification submitted by First Industries, Inc. for the device "VINYL ICE BAG". The FDA issued a decision of Substantially Equivalent on Mar 27, 1981. The device falls under product code KYR (Bag, Ice), a Class I device regulated under 21 CFR 880.6050. 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
- Bag, Ice
- Device Class
- Class I
- Regulation Number
- 880.6050
- Review Panel
- HO
- Submission Type
- 510(k) Exempt