The following data is part of a premarket notification filed by Ahlstrom Dexter with the FDA for Hydraspun M Sterilization Wrap.
Device ID | K933550 |
510k Number | K933550 |
Device Name: | HYDRASPUN M STERILIZATION WRAP |
Classification | Wrap, Sterilization |
Applicant | AHLSTROM DEXTER 2 ELM ST. Windsor Locks, CT 06096 |
Contact | J. Michael Joyce |
Correspondent | J. Michael Joyce AHLSTROM DEXTER 2 ELM ST. Windsor Locks, CT 06096 |
Product Code | FRG |
CFR Regulation Number | 880.6850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-07-21 |
Decision Date | 1994-03-29 |