The following data is part of a premarket notification filed by H & P Industries, Inc. with the FDA for Lubricating Jelly.
Device ID | K871169 |
510k Number | K871169 |
Device Name: | LUBRICATING JELLY |
Classification | Lubricant, Patient |
Applicant | H & P INDUSTRIES, INC. 9640 S 60TH ST. Franklin, WI 53132 |
Contact | Kishor Desai |
Correspondent | Kishor Desai H & P INDUSTRIES, INC. 9640 S 60TH ST. Franklin, WI 53132 |
Product Code | KMJ |
CFR Regulation Number | 880.6375 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-03-24 |
Decision Date | 1987-04-01 |