510(k) K871169
K871169 is an FDA 510(k) premarket notification submitted by H & P Industries, Inc. for the device "LUBRICATING JELLY". The FDA issued a decision of Substantially Equivalent on April 1, 1987. The device falls under product code KMJ (Lubricant, Patient), a Class I device regulated under 21 CFR 880.6375. H & P Industries, Inc. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 1, 1987
- Date Received
- March 24, 1987
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Lubricant, Patient
- Device Class
- Class I
- Regulation Number
- 880.6375
- Review Panel
- HO
- Submission Type