The following data is part of a premarket notification filed by Medical Creative Technologies, Inc. with the FDA for Protector Retractor & Protector Retractor With Drape.
Device ID | K954824 |
510k Number | K954824 |
Device Name: | PROTECTOR RETRACTOR & PROTECTOR RETRACTOR WITH DRAPE |
Classification | Drape, Surgical |
Applicant | MEDICAL CREATIVE TECHNOLOGIES, INC. 2950-N ADVANCE LN. Colmar, PA 18915 -9727 |
Contact | Perk Crook |
Correspondent | Perk Crook MEDICAL CREATIVE TECHNOLOGIES, INC. 2950-N ADVANCE LN. Colmar, PA 18915 -9727 |
Product Code | KKX |
CFR Regulation Number | 878.4370 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-10-20 |
Decision Date | 1996-04-23 |
Summary: | summary |