The following data is part of a premarket notification filed by Tactyl Technologies, Inc. with the FDA for Tactylon Tm Surgical Glove.
Device ID | K902831 |
510k Number | K902831 |
Device Name: | TACTYLON TM SURGICAL GLOVE |
Classification | Surgeon's Gloves |
Applicant | TACTYL TECHNOLOGIES, INC. 2595 COMMERCE WAY Vista, CA 92083 |
Contact | Buddenhagen |
Correspondent | Buddenhagen TACTYL TECHNOLOGIES, INC. 2595 COMMERCE WAY Vista, CA 92083 |
Product Code | KGO |
CFR Regulation Number | 878.4460 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-06-28 |
Decision Date | 1990-07-10 |