The following data is part of a premarket notification filed by Pharmacia Deltec, Inc. with the FDA for The Gripper Seal(tm).
Device ID | K870900 |
510k Number | K870900 |
Device Name: | THE GRIPPER SEAL(TM) |
Classification | Tape And Bandage, Adhesive |
Applicant | PHARMACIA DELTEC, INC. 1265 GREY FOX RD. St. Paul, MN 55112 |
Contact | Edward Numainville |
Correspondent | Edward Numainville PHARMACIA DELTEC, INC. 1265 GREY FOX RD. St. Paul, MN 55112 |
Product Code | KGX |
CFR Regulation Number | 880.5240 [🔎] |
Decision | Substantially Equivalent For Some Indications (SN) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-03-05 |
Decision Date | 1987-03-31 |