The following data is part of a premarket notification filed by A Plus International, Inc with the FDA for Suit, Surgical.
Device ID | K882282 |
510k Number | K882282 |
Device Name: | SUIT, SURGICAL |
Classification | Suit, Surgical |
Applicant | A PLUS INTERNATIONAL, INC 275 S. 3RD AVE. #2 La Puente, CA 91746 |
Contact | David Lee |
Correspondent | David Lee A PLUS INTERNATIONAL, INC 275 S. 3RD AVE. #2 La Puente, CA 91746 |
Product Code | FXO |
CFR Regulation Number | 878.4040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-05-31 |
Decision Date | 1988-06-23 |