The following data is part of a premarket notification filed by Repack Surgical Enterprises, Inc. with the FDA for Repak Surgical Pack (gown,towel,major,drape,basic).
Device ID | K880942 |
510k Number | K880942 |
Device Name: | REPAK SURGICAL PACK (GOWN,TOWEL,MAJOR,DRAPE,BASIC) |
Classification | General Surgery Tray |
Applicant | REPACK SURGICAL ENTERPRISES, INC. ONE KNOLLCREST DR. P.O. BOX 37890 Cincinnati, OH 45222 -1805 |
Contact | Rob Lowenstein |
Correspondent | Rob Lowenstein REPACK SURGICAL ENTERPRISES, INC. ONE KNOLLCREST DR. P.O. BOX 37890 Cincinnati, OH 45222 -1805 |
Product Code | LRO |
CFR Regulation Number | 878.4370 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-03-07 |
Decision Date | 1988-03-21 |