510(k) K771712
K771712 is an FDA 510(k) premarket notification submitted by Shield Laboratories, Inc. for the device "CATHETER DRESSING CHANCE SET". The FDA issued a decision of Substantially Equivalent on October 13, 1977. The device falls under product code FRL (Fiber, Medical, Absorbent), a Class I device regulated under 21 CFR 880.5300. Shield Laboratories, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 13, 1977
- Date Received
- September 12, 1977
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Fiber, Medical, Absorbent
- Device Class
- Class I
- Regulation Number
- 880.5300
- Review Panel
- HO
- Submission Type