510(k) K780608
K780608 is an FDA 510(k) premarket notification submitted by Abco Dealers, Inc. for the device "ICE BAG, VINYL". The FDA issued a decision of Substantially Equivalent on Jun 6, 1978. The device falls under product code KYR (Bag, Ice), a Class I device regulated under 21 CFR 880.6050. Abco Dealers, Inc. has 126 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jun 6, 1978
- Date Received
- Apr 10, 1978
- 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