510(k) K964364
K964364 is an FDA 510(k) premarket notification submitted by Instrument Makar, Inc. for the device "DISPOSABLE APRON". The FDA issued a decision of Substantially Equivalent on February 25, 1997. The device falls under product code LYU (Accessory, Surgical Apparel), a Class I device regulated under 21 CFR 878.4040. Instrument Makar, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 25, 1997
- Date Received
- November 1, 1996
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Accessory, Surgical Apparel
- Device Class
- Class I
- Regulation Number
- 878.4040
- Review Panel
- HO
- Submission Type